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2017 Federal Register Index

In 2017, the Food and Drug Administration published 794 documents.


Document Type Documents Published Subjects Covered
Rule 90 23
Proposed Rule 50 28
Notice 654 73
2017 Federal Register Index

This index provides descriptive entries and Federal Register page numbers for documents published by Food and Drug Administration in the daily Federal Register. It includes entries, with select metadata for all documents published in the 2017 calendar year.

Rules

Advisory Committee; Food Advisory Committee; Termination 1

Cardiovascular Devices; CFR Correction 1

Civil Money Penalty Definitions; Technical Amendment 1

Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding 'Intended Uses'; Further Delayed Effective Date 1

Food Additives Permitted in Feed and Drinking Water of Animals:

Ammonium Formate and Formic Acid 1
Gamma-Linolenic Acid Safflower Oil 1

Food Labeling:

Guidance:

Mitigation Strategies to Protect Food Against Intentional Adulteration; What You Need To Know About the Food and Drug Administration Regulation - Small Entity Compliance Guide 1
Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use 1
Same Surgical Procedure Exception: Questions and Answers Regarding the Scope of the Exception 1
Sanitary Transportation of Human and Animal Food: What You Need to Know About the Food and Drug Administration Regulation; Small Entity Compliance Guide 1
Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption: What You Need to Know About the Food and Drug Administration Regulation 1
Supply-Chain Program Requirements and Co-Manufacturer Supplier Approval and Verification for Human Food and Animal Food 1
Ultrafiltered Milk in the Production of Standardized Cheeses and Related Cheese Products 1

Humanitarian Use Devices; 21st Century Cures Act:

Technical Amendment 1

Immunology and Microbiology Devices:

Classification of Genetic Health Risk Assessment System 1

Indirect Food Additives:

Polymers 1

Listing of Color Additives Exempt from Certification:

Calcium Carbonate 1
Spirulina Extract 2
Titanium Dioxide and Listing of Color Additives Subject to Certification; [Phthalocyaninato (2-)] Copper; Confirmation of Effective Date 1

Medical Device Classification Procedures; Change of Address; Technical Amendment 1

Medical Devices:

Anesthesiology Devices; Classification of the External Negative Pressure Airway Aid 1
Cardiovascular Devices; Classification of Adjunctive Cardiovascular Status Indicator 1
Cardiovascular Devices; Classification of Balloon Aortic Valvuloplasty Catheter 1
Cardiovascular Devices; Classification of the Adjunctive Cardiovascular Status Indicator; Correction 1
Clinical Chemistry and Clinical Toxicology Devices; Classification of Acute Kidney Injury Test System 1
Clinical Chemistry and Clinical Toxicology Devices; Classification of Organophosphate Test System 1
Clinical Chemistry and Clinical Toxicology Devices; Classification of Reagents for Molecular Diagnostic Instrument Test Systems 1
Clinical Chemistry and Clinical Toxicology Devices; Classification of Total 25-hydroxyvitamin D Mass Spectrometry Test System 1
Clinical Chemistry and Clinical Toxicology Devices; Classification of the Continuous Glucose Monitor Secondary Display 1
Clinical Chemistry and Clinical Toxicology Devices; Classification of the High Throughput Genomic Sequence Analyzer for Clinical Use 1
Exemption From Premarket Notification; Class II Devices; Autosomal Recessive Carrier Screening Gene Mutation Detection System 1
Gastroenterology-Urology Devices; Classification of Enzyme Packed Cartridge 1
Gastroenterology-Urology Devices; Classification of Oral Removable Palatal Space Occupying Device for Weight Management and/or Weight Loss 2
Gastroenterology-Urology Devices; Classification of the High Intensity Ultrasound System for Prostate Tissue Ablation 1
Gastroenterology-Urology Devices; Classification of the Prostatic Artery Embolization Device 1
Gastroenterology-Urology Devices; Manual Gastroenterology-Urology Surgical Instruments and Accessories 1
General Hospital and Personal Use Devices; Classification of the Image Processing Device for Estimation of External Blood Loss 1
Hematology and Pathology Devices; Classification of Flow Cytometric Test System for Hematopoietic Neoplasms 1
Immunology and Microbiology Devices; Classification of Aquaporin-4 Autoantibody Immunological Test System 1
Immunology and Microbiology Devices; Classification of Assayed Quality Control Material for Clinical Microbiology Assays 1
Immunology and Microbiology Devices; Classification of Automated Image Assessment System for Microbial Colonies on Solid Culture Media 1
Immunology and Microbiology Devices; Classification of BCR-ABL Quantitation Test 1
Immunology and Microbiology Devices; Classification of Newborn Screening Test for Severe Combined Immunodeficiency Disorder 1
Immunology and Microbiology Devices; Classification of Nucleic Acid-Based Device for Amplification, Detection, and Identification of Microbial Pathogens Directly from Whole Blood Specimens 1
Immunology and Microbiology Devices; Classification of Streptococcus SPP. Nucleic Acid-Based Assay 1
Immunology and Microbiology Devices; Classification of the Automated Indirect Immunofluorescence Microscope and Software-Assisted System 1
Immunology and Microbiology Devices; Classification of the Device To Detect and Measure Non-Microbial Analyte(s) in Human Clinical Specimens To Aid in Assessment of Patients With Suspected Sepsis 1
Immunology and Microbiology Devices; Classification of the Device to Detect and Identify Microbial Pathogen Nucleic Acids in Cerebrospinal Fluid 1
Immunology and Microbiology Devices; Classification of the Mass Spectrometer System for Clinical Use for the Identification of Microorganisms 1
Immunology and Microbiology Devices; Classification of the Zinc Transporter 8 Autoantibody Immunological Test System 1
Neurological Devices, Classification of the Vibratory Counter-Stimulation Device 1
Neurological Devices; Classification of Computerized Behavioral Therapy Device for Psychiatric Disorders 1
Neurological Devices; Classification of Cranial Motion Measurement Device 1
Neurological Devices; Classification of Cranial Motion Measurement Device; Correction 1
Neurological Devices; Classification of External Vagal Nerve Stimulator for Headache 1
Neurological Devices; Classification of Non-Electroencephalogram Physiological Signal Based Seizure Monitoring System 1
Obstetrical and Gynecological Devices; Classification of Closed Loop Hysteroscopic Insufflator with Cutter-Coagulator 1
Obstetrical and Gynecological Devices; Classification of the Fetal Head Elevator 1
Obstetrical and Gynecological Devices; Classification of the Pressure Wedge for the Reduction of Cesarean Delivery 1
Obstetrical and Gynecological Devices; Reclassification of Surgical Instrumentation for Use With Urogynecologic Surgical Mesh 1
Ophthalmic Devices; Classification of the Tear Electrostimulation Device 1
Orthopedic Devices; Reclassification of Pedicle Screw Systems, Henceforth to be known as Thoracolumbosacral Pedicle Screw Systems, including Semi-Rigid Systems 1
Radiology Devices; Classification of Rectal Balloon for Prostate Immobilization 1

Microbiology Devices:

New Animal Drugs:

Approval of New Animal Drug Applications 1
Approval of New Animal Drug Applications; Change of Sponsor's Address 1
Investigational Use; Disqualification of a Clinical Investigator 1
Withdrawal Approval of New Animal Drug Applications; Change of Sponsor-Change of Sponsor's Name 1
Withdrawal Use in Animal Feed; Approval of New Animal Drug Applications 1
Withdrawal of Approval of New Animal Drug Applications 4
Withdrawal of Approval of New Animal Drug Applications; Change of Sponsor-Change of Sponsor's Address 1
Withdrawal of Approval of New Animal Drug Applications; Changes of Sponsorship 1

Presiding Officer for an Appeal and Informal Hearing 1

Refuse to Accept Procedures for Premarket Tobacco Product Submissions 1

Regulations Regarding "Intended Uses" Amendments:

Requirements to Submit Prior Notice of Imported Food; Technical Amendments 1

Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use 1

Sanitary Transportation of Human and Animal Food Rule:

Waivers from Requirements 1

Use of Ozone-Depleting Substances 1

Waivers Requirements of Sanitary Transportation of Human and Animal Food Rule; Correction 1

Proposed Rules

Animal Food Additive Petitions:

Akzo Nobel Surface Chemistry AB 1
Idemitsu Kosan, Cp. Ltd. 1
Zinpro Corp.; Reopening of the Comment Period 1

Approach to Evaluating Nicotine Replacement Therapies:

Public Hearing; Request for Comments 1

Center for Devices and Radiological Health:

Color Additive Petitions:

Colorcon, Inc. 1
DSM Biomedical 1
Environmental Defense Fund, Earthjustice, Environmental Working Group, Center for Environmental Health, et al. 1
Glo Eyes, LLC 1

Food Additive Petitions (Animal Use):

Akzo Nobel Surface Chemistry AB 1

Food Additive Petitions:

Akzo Nobel Surface Chemistry AB 2
Arcadia Biosciences, Inc. 1
BASF Corp. 1
Canadian Oilseed Processor Association 1
DSM Nutritional Products, Inc.; Withdrawal 2
Juice Products Association 1
Juice Products Association; Correction 1
Zinpro Corp. 2

Food Additive Petitions; Denials:

Natural Resources Defense Council et al. 1

Food Labeling:

Fruit Juice and Vegetable Juice as Color Additives in Food 1

General Hospital and Personal Use Devices; Reclassification of Sharps Needle Destruction Device 1

Guidance:

Labeling of Human Food Products:

Use of the Term Healthy; Public Meeting 1

Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products 1

Medical Devices:

Obstetrical and Gynecological Devices:

Prescribing Intervention--Exploring Strategy for Implementation

Opioid Policy Steering Committee; Public Hearing 1

Review of Existing Center for Biologics Evaluation and Research Regulatory and Information Collection Requirements 1

Review of Existing Center for Devices and Radiological Health Regulatory and Information Collection Requirements 1

Review of Existing Center for Drug Evaluation and Research Regulatory and Information Collection Requirements 1

Review of Existing Center for Food Safety and Applied Nutrition Regulatory and Information Collection Requirements 1

Review of Existing Center for Tobacco Products Regulatory and Information Collection Requirements 1

Review of Existing Center for Veterinary Medicine Regulatory and Information Collection Requirements 1

Review of Existing General Regulatory and Information Collection Requirements of Food and Drug Administration 1

Review of Existing Regulatory and Information Collection Requirements; Extension of Comment Period 1

Scientific Evaluation of the Evidence on the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates Submitted as a Citizen Petition 1

Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption; Correction 1

Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption; Extension of Compliance Dates 1

Tobacco Product Standard for N-Nitrosonornicotine Level in Finished Smokeless Tobacco Products 2

Notices

21st Century Cures Act:

Abbreviated New Drug Applications; Approval Withdrawals:

Advice About Eating Fish; Revised Fish Advice 1

Advisory Committee Nominations:

Agency Information Collection Activities; Proposals, Submissions, and Approvals 6

Agency Information Collection Activities; Proposals, Submissions, and Approvals:

513(g) Request for Information 1
Accredited Person under Accredited Persons Inspection Program 1
Additional Criteria and Procedures for Classifying Over-the-Counter Drugs as Generally Recognized as Safe and Effective and Not Misbranded 2
Adverse Event Program for Medical Devices 1
Adverse Event Program for Medical Devices (Medical Product Safety Network) 1
Adverse Experience Reporting for Licensed Biological Products; and General Records 1
Advisory Committee Nomination Applications 1
Animal Drug Adverse Event Reporting and Recordkeeping 1
Animal Drug User Fee Act Waivers and Reductions 1
Animal Drug User Fee Cover Sheet 1
Animal Generic Drug User Fee Act Cover Sheet 1
Announcement of Office of Management and Budget Approvals 2
Annual Reporting for Custom Device Exemption 2
Application for Participation in Fellowship Programs 1
Application for Participation in Food and Drug Administration Fellowship Programs 1
Applications for Approval To Market a New Drug 1
Applications for Food and Drug Administration Approval to Market a New Drug 2
Blood Establishment Registration and Product Listing 1
Calorie Labeling of Articles of Food in Vending Machines 1
Certification of Identity for Freedom of Information Act and Privacy Act Requests 1
Certification to Accompany Drug, Biological Product, and Device Applications or Submissions 1
Channels of Trade Policy for Commodities with Residues of Pesticide Chemicals, for Which Tolerances have been Revoked, Suspended, or Modified, etc. 1
Channels of Trade Policy for Commodities with Residues of Pesticide Chemicals, for which Tolerances have been Revoked, Suspended, or Modified by the Environmental Protection Agency pursuant to Dietary Risk Considerations 1
Character-Space-Limited Online Prescription Drug Communications 1
Citizen Petitions and Petitions for Stay of Action 1
Citizen Petitions and Petitions for Stay of Action Subject to the Federal Food, Drug, and Cosmetic Act 1
Class II Special Controls Guidance Document: Labeling Natural Rubber Latex Condoms 1
Collection of Nominations for Candidates to Serve on Food and Drug Administration's Advisory Committees 1
Color Additive Certification Requests and Recordkeeping 2
Consumer and Healthcare Professional Identification of and Responses to Deceptive Prescription Drug Promotion 2
Content and Format of Labeling for Human Prescription Drugs and Biological Products; Requirements for Pregnancy and Lactation Labeling 1
Cosmetic Labeling Regulations 2
Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals 1
Current Good Manufacturing Practice Regulations for Medicated Feeds 1
Current Good Manufacturing Practice Regulations for Type A Medicated Articles 1
Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements 1
Customer/Partner Service Surveys 2
Data To Support Drug Product Communications as Used by the Food and Drug Administration 1
Data To Support Social and Behavioral Research as Used by the Food and Drug Administration 1
Data to Support Drug Product Communications as Used by Food and Drug Administration 1
De Novo Classification Process 1
Disclosures in Professional and Consumer Prescription Drug Promotion 1
Disclosures of Descriptive Presentations in Professional Oncology Prescription Drug Promotion 1
Dispute Resolution Procedures for Science-Based Decisions on Products Regulated by the Center for Veterinary Medicine 1
Draft Guidance for Industry and Review Staff on Target Product Profile--A Strategic Development Process Tool 1
Draft Guidance for Industry; How to Prepare a Pre-Request for Designation 1
Electronic Products 1
Electronic Records; Electronic Signatures 1
Electronic Signatures 1
Electronic Submission Process for Voluntary Allegations to the Center for Devices and Radiological Health 2
Establishing and Maintaining Lists of U.S. Milk Product 1
Establishing and Maintaining Lists of U.S. Milk Product Manufacturers/Processors With Interest in Exporting 1
Establishing and Maintaining Lists of United States Manufacturers/Processors with Interest in Exporting Center for Food Safety and Applied Nutrition-Regulated Products to China 2
Establishment Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution and Blood Establishment Registration and Product Listing 1
Evaluation of the Food and Drug Administration's 'Fresh Empire' Multicultural Youth Tobacco Prevention Campaign 1
Evaluation of the Food and Drug Administration's Education at the Point of Sale Campaign 1
Exception from General Requirements for Informed Consent 1
Exceptions or Alternatives to Labeling Requirements for Products Held by Strategic National Stockpile 2
Experimental Study of Risk Information Amount and Location in Direct-to-Consumer Print Ads 1
Experimental Study on Warning Statements for Cigarette Graphic Health Warnings 2
Export of Food and Drug Administration-Regulated Products - Export Certificates 1
Extralabel Drug Use in Animals 1
Focus Groups about Drug Products as Used by Food and Drug Administration 1
Focus Groups as Used by Food and Drug Administration 1
Focus Groups as Used by the Food and Drug Administration 1
Food Additive, Color Additive (Including Labeling), Submission of Information to Master File in Support of Petitions; and Electronic Submission Using Food and Drug Administration Form 3503 1
Food Additive, Color Additive (Including Labeling), Submission of Information to a Master File in Support of Petitions; and Electronic Submission Using Food and Drug Administration 1
Food Allergen Labeling and Reporting 1
Food Canning Establishment Registration, Process Filing, and Recordkeeping for Acidified Foods and Thermally Processed Low-Acid Foods in Hermetically Sealed Containers 2
Food Labeling Regulations 1
Food Safety Survey 2
Food and Drug Administration Rapid Response Surveys 1
Food and Drug Administration Rapid Response Surveys (Generic Clearance) 1
Food and Drug Administration Recall Regulations 1
Food and Drug Administration Safety Communication Readership Survey 1
Generic Clearance for the Collection of Qualitative Data on Tobacco Products and Communications 1
Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery 2
Good Clinical Practice; International Council for Harmonisation 1
Good Laboratory Practice Regulations for Nonclinical Studies 2
Guidance for Industry -- User Fee Waivers, Reductions, and Refunds for Drug and Biological Products 1
Guidance for Industry on Expedited Programs for Serious Conditions--Drugs and Biologics 1
Guidance for Industry on Expedited Programs for Serious Conditions: Drugs and Biologics 1
Guidance for Industry on Fees for Human Drug Compounding Outsourcing Facilities under Federal Food, Drug, and Cosmetic Act 1
Guidance for Industry on Fees for Human Drug Compounding Outsourcing Facilities under the Federal Food, Drug, and Cosmetic Act 1
Guidance for Industry on Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical Current Good Manufacturing Practice 1
Guidance for Industry on Pharmacogenomic Data Submissions 2
Guidance for Industry on Planning for Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products 1
Guidance for Industry on Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic 1
Guidance for Industry on Registration of Human Drug Compounding Outsourcing Facilities under Federal Food, Drug, and Cosmetic Act 1
Guidance for Industry on Registration of Human Drug Compounding Outsourcing Facilities under Section 503B of Federal Food, Drug, and Cosmetic Act 1
Guidance for Industry on Special Protocol Assessment 1
Guidance for Industry, Researchers, Patient Groups, and Food and Drug Administration Staff on Meetings With the Office of Orphan Products Development 1
Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics 1
Guidance for Industry: User Fee Waivers, Reductions, and Refunds for Drug and Biological Products 1
Guidance on Consultation Procedures - Foods Derived from New Plant Varieties 1
Hazard Analysis and Critical Control Point Procedures for Safe and Sanitary Processing and Importing of Juice 1
Health and Diet Survey, as Used by Food and Drug Administration 1
Health and Diet Survey, as Used by the Food and Drug Administration 1
Human Cells, Tissues, and Cellular and Tissue-Based Products: Establishment Registration and Listing; Eligibility Determination for Donors; and Current Good Tissue Practice 1
Import Trade Auxiliary Communication System 1
Imported Food under Public Health Security and Bioterrorism Preparedness and Response 1
Index of Legally Marketed Unapproved New Animal Drugs for Minor Species 1
Infant Formula Recall Regulations 2
Infant Formula Requirements 1
Information from United States Firms and Processors That Export to the European Union 1
Institutional Review Boards 1
Medical Devices; Device Tracking 1
Medical Devices; Exception from General Requirements for Informed Consent 1
Medical Devices; Humanitarian Use Devices 1
Medical Devices; Reports of Corrections and Removals 1
Orphan Drug Designation Request Form and The Common European Medicines Agency/Food and Drug Administration Form for Orphan Medicinal Product Designation 1
Orphan Drugs; Common European Medicines Agency/Food and Drug Administration Application Form for Orphan Drug Medicinal Product Designation 1
Patent Term Restoration, Due Diligence Petitions, Filing, Format, and Content of Petitions 1
Postmarketing Safety Reports for Human Drug and Biological Products 1
Potential Tobacco Product Violations Reporting Form 1
Premarket Approval of Medical Devices 1
Premarket Notification 1
Premarket Notification for a New Dietary Ingredient 1
Prescription Drug Advertisements 2
Prescription Drug Marketing Act of 1987; Administrative Procedures, Policies, and Requirements 1
Prior Notice of Imported Food under Public Health Security and Bioterrorism Preparedness and Response Act of 2002 1
Prominent and Conspicuous Mark of Manufacturers on Single-Use Devices 1
Providing Information About Pediatric Uses of Medical Devices 1
Providing Waiver-Related Materials in Accordance with Guidance for Industry on Providing Post-market Periodic Safety Reports in International Conference on Harmonisation E2C(R2) Format 2
Radioactive Drug Research Committees 2
Recommended Glossary and Educational Outreach to Support use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use 1
Recordkeeping and Records Access Requirements for Food Facilities 2
Recordkeeping and Reporting Requirements for Human Food and Cosmetics Manufactured From, Processed With, or Otherwise Containing Material From Cattle 1
Recordkeeping and Reporting Requirements for Human Food and Cosmetics Manufactured from, Processed with, or Otherwise Containing Material from Cattle 1
Regulations for In Vivo Radiopharmaceuticals Used for Diagnosis and Monitoring 1
Reports of Corrections and Removals 1
Requirement for Submission of Information on Pediatric Subpopulations That Suffer from a Disease or Condition That Device is Intended to Treat, Diagnose, or Cure 1
Safety Assurance Case 1
Safety Assurance Case; Withdrawal 1
Safety Communication Readership Survey 1
State Petitions for Exemption From Preemption 2
Substances Prohibited From Use in Animal Food or Feed 1
Substantiation for Dietary Supplement Claims Made Under the Federal Food, Drug, and Cosmetic Act 1
Survey of Alumni Commissioner's Fellowship Program Fellows 1
Temporary Marketing Permit Applications 2
Testing Communications on Medical Devices and Radiation-Emitting Products 1
Third Party Disclosure and Recordkeeping Requirements for Reportable Food 2
Tracking Network for PETNet, LivestockNet, and SampleNet 1
Use of Serological Tests to Reduce the Risk of Transmission of Trypanosoma cruzi Infection in Whole Blood and Blood Components for Transfusion 1
Utilization of Adequate Provision Among Low to Non-Internet Users 1
Voluntary Cosmetic Registration Program 2
Voluntary National Retail Food Regulatory Program Standards 2

Analysis Data Reviewer's Guide 1

Animal Drug User Fee Rates and Payment Procedures for Fiscal Year 2018 1

Animal Generic Drug User Fee Rates and Payment Procedures for Fiscal Year 2018 1

Biosimilar User Fee Rates for Fiscal Year 2018 1

Center for Devices and Radiological Health Premarket Approval Application Critical to Quality Pilot Program 1

Center for Devices and Radiological Health:

Experiential Learning Program 2

Charter Renewals:

Advisory Committee; Technical Electronic Product Radiation Safety Standards Committee 1
Medical Imaging Drugs Advisory Committee 1
National Mammography Quality Assurance Advisory Committee 1
Nonprescription Drugs Advisory Committee 1
Patient Engagement Advisory Committee 1

Content of Risk Information in Major Statement in Prescription Drug Direct-to-Consumer Broadcast Advertisements 1

Debarment Orders:

Karis Copper Delong 1
Keith J. Pierce 1
Matthew Schroeder 1
Raymond Sean Brown 1
Trand Doan Nguyen 1

Determinations of Regulatory Review Periods for Purposes of Patent Extensions:

ADVANTAME 1
ADYNOVATE 1
EMPLICITI 1
HETLIOZ 1
IMPELLA 2.5 SYSTEM 1
INSPIRE UPPER AIRWAY STIMULATION SYSTEM 1
KENGREAL 1
KOVALTRY 1
MITRACLIP CDS 1
NATPARA 1
NEUROPACE RNS SYSTEM 1
OBIZUR 1
RAPIVAB 1
RECUVYRA 1
RECUVYRA; Affirmation 1
SIVEXTRO 1
STRIVERDI RESPIMAT 1
TECFIDERA 1
XTORO 1
ZYKADIA 1

Determinations that Products Were Not Withdrawn from Sale for Reasons of Safety or Effectiveness:

CALCIJEX (Calcitriol) Injectable, 1 Microgram/Milliliter and 2 Micrograms/Milliliter 1
CARDENE SR (Nicardipine HCl) Extended-Release Capsules, 30 Milligrams, 45 Milligrams, and 60 Milligrams 1
CEDAX (Ceftibuten Dihydrate) for Oral Suspension, 90 Milligrams/5 Milliliters and 180 Milligrams/5 Milliliters 1
CENESTIN (estrogens, conjugated synthetic A) Tablets, 0.3 Milligrams, 0.45 Milligrams, 0.625 Milligrams, 0.9 Milligrams, and 1.25 Milligrams 1
CORDARONE (Amiodarone Hydrochloride) Tablets, 200 milligrams 1
CORTONE (Cortisone Acetate) Tablets and Other Drug Products 1
CYANOCOBALAMIN INJECTION, 1Milligram per Milliliter in a 10 Milliliter Vial 1
DEMEROL (Meperidine Hydrochloride) Injectable and Other Drug Products 1
ELAVIL (Amitriptyline Hydrochloride) Oral Tablets, 10, 25, 50, 75, 100, and 150 Milligrams 1
ENJUVIA (estrogens, conjugated synthetic B) Tablets, 0.625 Milligrams and 1.25 Milligrams 1
FLONASE (Fluticasone Propionate) Nasal Spray, 0.05 Milligram 1
GYNOREST (Dydrogesterone) Oral Tablets, 5 Milligrams and 10 Milligrams 1
METICORTEN (Prednisone) Tablets, 1 Milligram and 5 Milligrams 1
NIZORAL (Ketoconazole) Tablets, 200 Milligrams 1
NOROXIN (Norfloxacin) Tablets, 400 Milligrams 1
OVRETTE (Norgestrel) Tablet, 0.075 Milligrams 1
REVEX (Nalmefene Hydrochloride Injection), 0.1 Milligram Base/Milliliter and 1.0 Milligram Base/Milliliter 1
RITALIN LA (Methylphenidate Hydrochloride) Extended-Release Capsules, 60 Milligrams 1
SPECTAZOLE (Econazole Nitrate) Topical Cream, 1% 1
SYMMETREL (Amantadine Hydrochloride), Syrup, 50 milligrams/5 Milliliters 1
TIMOPTIC (Timolol Maleate Ophthalmic Solution), 0.25 Percent and 0.5 Percent 1
TRINTELLIX (Vortioxetine Hydrobromide) Oral Tablet, EQ 15 Milligram Base 1

Determinations that Products Were Withdrawn from Sale for Reasons of Safety or Effectiveness:

Docket Establishments:

Draft Revisions to the Food and Drug Administration Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioids; Availability 1

Draft Standardization of Pharmaceutical Quality/Chemistry Manufacturing and Control Data Elements and Terminologies 1

Electronic Study Data Submission; Data Standards:

Emergency Use Authorizations:

In Vitro Diagnostic Devices for Detection of Zika Virus 1

Emergency Use; Authorizations:

Emergency Uses; Authorizations:

In Vitro Diagnostic Devices for Detection of Zika Virus 1

Enhancing Patient Engagement Efforts Across the Food and Drug Administration 1

Extension of the Timetable Requirement to Submit Study Data in Logical Observation Identifiers Names and Codes 1

Fee Rates:

Filing of Advisory Committees Closed Meeting Reports 1

Fiscal Year 2017 Performance Review Board Members 1

Flavor Developer and Manufacturer Site Tours Program 1

Food Safety Modernization Act Third-Party Certification Program User Fee Rate for Fiscal Year 201 1

Food and Drug Administration Modernization Act:

Fostering Medical Innovation - Plan for Digital Health Devices; Software Precertification Pilot Program 1

Fostering Medical Innovation:

Generic Drug User Fee Amendments II Program Fee:

Generic Drug User Fee Rates for Fiscal Year 2018 1

Government-Owned Inventions; Availability for Licensing 1

Guidance:

180-Day Exclusivity -- Questions and Answers 1
Abbreviated New Drug Applications - Pre-Submission of Facility Information Related to Prioritized Generic Drug Applications (Pre-Submission Facility Correspondence) 1
Abbreviated New Drug Applications Submissions--Amendments to Abbreviated New Drug Applications under Generic Drug User Fee Act 1
Abbreviated New Drug Applications Submissions--Refuse-to-Receive Standards: Questions and Answers 1
Abbreviated New Drug Applications for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of Recombinant Deoxyribonucleic Acid Origin 2
Acceptance Review for De Novo Classification Requests 1
Advancement of Emerging Technology Applications for Pharmaceutical Innovation and Modernization 1
Amendment to "Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Products" 1
Animal Drug User Fees and Fee Waivers and Reductions 1
Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers 1
Antibacterial Therapies for Patients with Unmet Medical Need for Treatment of Serious Bacterial Diseases 1
Application of the "Solely Engaged" Exemptions 1
Assessing User Fees Under the Biosimilar User Fee Amendments of 2017 1
Assessing User Fees Under the Prescription Drug User Fee Amendments of 2017 1
Assessing User Fees under Generic Drug User Fee Amendments of 2017 1
Assessment of Abuse Potential of Drugs 1
Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection of Zika Virus; Availability; Correction 1
Best Practices for Communication Between Investigational New Drug Application Sponsors and the Food and Drug Administration 1
Bioequivalence Recommendations for Difluprednate 1
Breakthrough Devices Program 1
Categorization of Investigational Device Exemption Devices to Assist the Centers for Medicare and Medicaid Services with Coverage Decisions 1
Changes to Existing Medical Software Policies Resulting From Section 3060 of the 21st Century Cures Act 1
Chemistry, Manufacturing, and Controls Changes to an Approved Application - Certain Biological Products 1
Chemistry, Manufacturing, and Controls Postapproval Manufacturing Changes for Specified Biological Products To Be Documented in Annual Reports 1
Child-Resistant Packaging Statements in Drug Product Labeling 1
Chronic Hepatitis C Virus Infection; Developing Direct-Acting Antiviral Drugs for Treatment 1
Clarification of Orphan Designation of Drugs and Biologics for Pediatric Subpopulations of Common Diseases 1
Clarification of the Food and Drug Administration and Environmental Protection Agency Jurisdiction Over Mosquito-Related Products 1
Classification and Requirements for Laser Illuminated Projectors 1
Classification of Products as Drugs and Devices and Additional Product Classification Issues 1
Clinical and Patient Decision Support Software 1
Comparative Analyses and Related Comparative Use Human Factors Studies for Drug-Device Combination Product Submitted in Abbreviated New Drug Application 1
Compliance Policy for Required Warning Statements on Small-Packaged Cigars 2
Considerations in Demonstrating Interchangeability with Reference Product 2
Consumer Antiseptic Wash Final Rule Questions and Answers; Small Entity Compliance Guide 1
Controlled Correspondence Related to Generic Drug Development 1
Controlled Correspondence Related to Generic Drug Development; Correction 1
Current Good Manufacturing Practice Requirements for Combination Products 1
Current Good Manufacturing Practice Requirements for Food for Animals 1
Current Good Manufacturing Practice for Medical Gases 1
De Novo Classification Process (Evaluation of Automatic Class III Designation) 1
Deciding When To Submit a 510(k) for a Change to an Existing Device 1
Deciding When To Submit a 510(k) for a Software Change to an Existing Device 1
Delayed Graft Function in Kidney Transplantation: Developing Drugs for Prevention 1
Design Considerations and Premarket Submission Recommendations for Interoperable Medical Devices 1
Determining Whether to Submit an Abbreviated New Drug Application or a 505(b)(2) Application 1
Developing Targeted Therapies in Low-Frequency Molecular Subsets of a Disease 1
Deviation Reporting for Human Cells, Tissues, and Cellular and Tissue-Based Products 1
Display Devices for Diagnostic Radiology 1
Drug Products Labeled as Homeopathic 1
Drug Products, Including Biological Products, that Contain Nanomaterials 1
Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities: Questions and Answers 1
Electronic Drug Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act 1
Electronic Study Data Submission; Data Standards; Support End Date for Study Data Tabulation Model Version 1.2, Implementation Guide Version 3.1.2, and Implementation Guide Version 3.1.2, Amendment 1 1
Electronic Study Data Submission; Data Standards; Support for Analysis Data Model Implementation Guide Version 1.1 1
Electronic Study Data Submission; Data Standards; Support for Standard for Exchange of Nonclinical Data Implementation Guide Version 3.1 1
Electronic Study Data Submission; Data Standards; Support for Version Update of Medical Dictionary for Regulatory Activities 1
Emergency Use Authorization of Medical Products and Related Authorities 1
Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Human Papillomaviruses 1
Evaluating Drug Effects on Ability to Operate Motor Vehicle 1
Evaluation and Reporting of Age, Race, and Ethnicity Data in Medical Device Clinical Studies 1
Evaluation of Devices Used With Regenerative Medicine Advanced Therapies 1
Expedited Programs for Regenerative Medicine Therapies for Serious Conditions 1
Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products 1
Extending Expiration Dates of Doxycycline Tablets and Capsules in Strategic Stockpiles 1
Extension of Certain Tobacco Product Compliance Deadlines Related to Final Deeming Rule 1
Factors to Consider When Making Benefit-Risk Determinations for Medical Device Investigational Device Exemptions 1
Formal Dispute Resolution: Sponsor Appeals Above the Division Level 1
Formal Meetings Between Food and Drug Administration and Abbreviated New Drug Application Applicants of Complex Products under Generic Drug User Fee Act 1
Formal Meetings Between the Food and Drug Administration and Sponsors or Applicants of Prescription Drug User Fee Act Products 1
Format and Content of a Risk Evaluation and Mitigation Strategy Document 1
General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products 1
Generic Drug User Fee Amendments of 2012: Questions and Answers Related to Self-Identification of Facilities, Review of Generic Drug Submissions, and Inspections and Compliance 1
Genome Editing in New Plant Varieties Used For Foods 1
Genome Editing in New Plant Varieties Used for Foods 1
Gluten in Drug Products and Associated Labeling Recommendations 1
Grandfathering Policy for Packages and Homogenous Cases of Product Without Product Identifier 1
How to Prepare a Pre-Request for Designation 1
Identifying Trading Partners under Drug Supply Chain Security Act 3
Implementation of Pathogen Reduction Technology in the Manufacture of Blood Components in Blood Establishments: Questions and Answers 1
In Vitro Metabolism- and Transporter-Mediated Drug-Drug Interaction Studies, and Clinical Drug Interaction Studies--Study Design, Data Analysis, and Clinical Implications 1
In-Use Stability Studies and Associated Labeling Statements for Multiple-Dose Injectable Animal Drug Products 1
Information Requests and Discipline Review Letters Under the Generic Drug User Fee Amendments 1
Institutional Review Board Waiver or Alteration of Informed Consent for Clinical Investigations Involving No More Than Minimal Risk to Human Subjects 1
International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: General Approach to Establish an Acute Reference Dose 1
Interpretation of and Compliance Policy for Certain Label Requirement; Applicability of Certain Federal Food, Drug, and Cosmetic Act Requirements to Vape Shops 1
Investigational In Vitro Diagnostics Used in Clinical Investigations of Therapeutic Products 1
Labeling of Red Blood Cell Units with Historical Antigen Typing Results 1
M4 Organization of Common Technical Document for Registration of Pharmaceuticals for Human Use; International Council for Harmonisation 1
M4E(R2): Common Technical Document--Efficacy; International Council for Harmonisation 1
Manufacturers Sharing Patient-Specific Information from Medical Devices with Patients upon Request 1
Marketing Clearance of Diagnostic Ultrasound Systems and Transducers 1
Medical Product Communications Consistent with Required Labeling: Questions and Answers 1
Microdose Radiopharmaceutical Diagnostic Drugs: Nonclinical Study Recommendations 1
Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application 1
Multiple Endpoints in Clinical Trials 1
Nonproprietary Naming of Biological Products 1
Oncology Drugs for Companion Animals 1
Oncology Pharmaceuticals - Reproductive Toxicity Testing and Labeling Recommendations 1
Pediatric Gastroesophageal Reflux Disease; Developing Drugs for Treatment 1
Pediatric Information for X-ray Imaging Device Premarket Notifications 1
Pediatric Rare Diseases: Collaborative Approach for Drug Development Using Gaucher Disease as Model 1
Policy Clarification and Premarket Notification (510(k)) Submissions for Ultrasonic Diathermy Devices 1
Post-Complete Response Letter Meetings between Food and Drug Administration and Abbreviated New Drug Application Applicants under Generic Drug User Fee Act 1
Premarket Notification Submissions for Bone Anchors 1
Procedures for Meetings of Medical Devices Advisory Committee 1
Product Identifier Requirements under Drug Supply Chain Security Act: Compliance Policy 1
Product Labeling for Certain Ultrasonic Surgical Aspirator Devices 1
Product Name Placement, Size, and Prominence in Promotional Labeling and Advertisements 1
Product-Specific Guidance for Digoxin 1
Product-Specific Guidance for Methylphenidate Hydrochloride 1
Product-Specific Guidance for Naloxone Hydrochloride 1
Product-Specific Guidance for Tiotropium Bromide 1
Product-Specific Guidances 2
Product-Specific Guidances for Rifaximin 1
Product-Specific Guidances for Salmeterol Xinafoate and Fluticasone Propionate 1
Product-Specific Guidances; Availability 1
Product-Specific Guidances; Draft and Revised Draft Guidances for Industry 1
Prohibition of Distributing Free Samples of Tobacco Products 2
Proposed Method for Adjusting Data on Antimicrobials Sold or Distributed for Use in Food-Producing Animals Using a Biomass Denominator 1
Providing Regulatory Submissions in Electronic Format--Content of Risk Evaluation and Mitigation Strategies Document Using Structured Product Labeling 1
Q11 Development and Manufacture of Drug Substances--Questions and Answers (Selection and Justification of Starting Materials); International Council for Harmonisation 1
Qualification of Medical Device Development Tools 1
Questions and Answers on Nutrition and Supplement Facts Labels Related to Compliance Date, Added Sugars, and Declaration of Quantitative Amounts of Vitamins and Minerals 1
Recommendations for Assessment of Blood Donor Eligibility, Donor Deferral and Blood Product Management in Response to Ebola Virus 1
Recommendations for Dual 510(k) and Clinical Laboratory Improvement Amendments Waiver by Application Studies 1
Recommendations for Permitted Daily Exposures for Two Solvents, Triethylamine and Methylisobutylketone. etc. 1
Recommended Statement for Over-the-Counter Aspirin-Containing Drug Products Labeled With Cardiovascular Related Imagery 1
Recommended Statement for Over-the-Counter Aspirin-Containing Drug Products Labeled with Cardiovascular-Related Imagery 1
Recommended Warning for Over-the-Counter Acetaminophen-Containing Drug Products and Labeling Statements Regarding Serious Skin Reactions 1
Recurrent Herpes Labialis - Developing Drugs for Treatment and Prevention 1
Reference Amounts Customarily Consumed: List of Products for Each Product Category 1
Referencing Approved Drug Products in Abbreviated New Drug Application Submissions 1
Refusal of Inspection by a Foreign Food Establishment or Foreign Government 1
Refuse to File - New Drug Application and Biologics License Application Submissions to the Center for Drug Evaluation and Research 1
Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments 2
Regulation of Intentionally Altered Genomic DNA in Animals 2
Regulation of Mosquito-Related Products 1
Regulatory Considerations for Microneedling Devices 1
Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities 1
Replacement Reagent and Instrument Family Policy for In Vitro Diagnostic Devices 1
Requests for Reconsideration at the Division Level Under the Generic Drug User Fee Act 1
Respiratory Syncytial Virus Infection: Developing Antiviral Drugs for Prophylaxis and Treatment 1
S5(R3) Detection of Toxicity to Reproduction for Human Pharmaceuticals; International Council for Harmonisation 1
Select Updates for Recommendations for Clinical Laboratory Improvement Amendments of 1988 Waiver Applications for Manufacturers of In Vitro Diagnostic Devices 1
Software as a Medical Device - Clinical Evaluation 1
Standards Development and the Use of Standards in Regulatory Submissions Reviewed in the Center for Biologics Evaluation and Research 1
Statistical Approaches to Evaluate Analytical Similarity 1
Statistical Principles for Clinical Trials: Addendum: Estimands and Sensitivity Analysis in Clinical Trials; International Council for Harmonisation 1
Study Design Recommendations for Residue Studies in Honey for Establishing Maximum Residue Limits and Withdrawal Periods 1
Submission of Quality Metrics Data; Extension of Comment Period 1
Technical Considerations for Additive Manufactured Medical Devices 1
The Index of Legally Marketed Unapproved New Animal Drugs for Minor Species 1
The Least Burdensome Provisions; Concept and Principles 1
Three-Month Extension of Certain Tobacco Product Compliance Deadlines Related to the Final Deeming Rule 1
Unique Device Identification: Direct Marking of Devices 1
Use of Drug Master File for Shared System Risk Evaluation and Mitigation Strategy Submissions 1
Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices 1
Use of Serological Tests to Reduce Risk of Transmission of Trypanosoma cruzi Infection in Blood and Blood Components 1
Utilizing Animal Studies to Evaluate Organ Preservation Devices 1
Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System 1

Information Available to Industry:

Training Program for Regulatory Project Managers 1

International Drug Scheduling:

International Drug Scheduling; Convention on Psychotropic Substances:

Issuance of Priority Review Voucher; Rare Pediatric Disease Product 1

Medical Devices:

Meetings:

2017 Scientific Meeting of the National Antimicrobial Resistance Monitoring System 1
Administering Hatch-Waxman Amendments - Ensuring Balance Between Innovation and Access 1
Administering the Hatch-Waxman Amendments: Ensuring a Balance Between Innovation and Access 1
Advancing Development of Pediatric Therapeutics: Application of Big Data to Pediatric Safety Studies; Public Workshop 1
Agricultural Biotechnology Education and Outreach Initiative 1
Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee 1
Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Establishment of a Public Docket 1
Anesthetic and Analgesic Drug Products Advisory Committee, Drug Safety and Risk Management Advisory Committee; Establishment of Public Docket 1
Animal Drug User Fee Act 1
Animal Generic Drug User Fee Act 1
Antibody Mediated Rejection in Kidney Transplantation; Public Workshop 1
Antimicrobial Drugs Advisory Committee 1
Antimicrobial Drugs Advisory Committee; Establishment of Public Docket 1
Antimicrobial Drugs Advisory Committee; Establishment of a Public Docket 1
Antimicrobial Susceptibility and Resistance: Addressing Challenges of Diagnostic Devices; Public Workshop 1
Arthritis Advisory Committee 1
Arthritis Advisory Committee; Establishment of Public Docket; Request for Comments 1
Assessment of Food and Drug Administration Hiring and Retention 1
Bacteriophage Therapy: Scientific and Regulatory Issues; Public Workshop 1
Battery Safety Concerns in Electronic Nicotine Delivery Systems; Public Workshop 1
Benefit-Risk Assessments in Drug Regulatory Decision-Making 1
Blood Products Advisory Committee 1
Blood Products Advisory Committee Advisory Committee 1
Bone, Reproductive and Urologic Drugs Advisory Committee 2
Bone, Reproductive and Urologic Drugs Advisory Committee; Establishment of a Public Docket 1
Cardiac Troponin Assays; Public Workshop 1
Cardiac Troponin Assays; Workshop 1
Cellular, Tissue, and Gene Therapies Advisory Committee 1
Center for Drug Evaluation and Research Small Business and Industry Assistance Regulatory Education for Industry Generic Drugs Forum 1
Circulatory System Devices Panel of the Medical Devices Advisory Committee 1
Clinical Trial Requirements, Regulations, Compliance, and Good Clinical Practice; Public Workshop 1
Current State and Further Development of Animal Models of Serious Infections Caused by Acinetobacter baumannii and Pseudomonas aeruginosa; Public Workshop 1
Cybersecurity of Medical Devices - A Regulatory Science Gap Analysis; Public Workshop 1
Data and Methods for Evaluating the Impact of Opioid Formulations With Properties Designed to Deter Abuse in the Postmarket Setting: A Scientific Discussion of Present and Future Capabilities; Public Workshop; Issues Paper 1
Dermatologic and Ophthalmic Drugs Advisory Committee; Establishment of a Public Docket; Request for Comments 1
Developing Rabies Monoclonal Antibody Products as Component of Rabies Post-Exposure Prophylaxis; Public Workshop 1
Developing a Framework for Regulatory Use of Real-World Evidence; Public Workshop 1
Development of New Tuberculosis Treatment Regimens--Scientific and Clinical Trial Design Considerations; Public Workshop 1
Development of a List of Pre-Dietary Supplement Health and Education Act Dietary Ingredients 1
Devices Proposed for New Use with Approved, Marketed Drug; Public Hearing 1
Drug Development in Pediatric Heart Failure: Extrapolation, Clinical Trial Design, and Endpoints; Public Workshop 1
Drug Safety and Risk Management Advisory Committee and Anesthetic and Analgesic Drug Products Advisory Committee; Correction 1
Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee 1
Emerging Tick-Borne Diseases and Blood Safety; Public Workshop 1
Endocrinologic and Metabolic Drugs Advisory Committee 2
Enhanced Drug Distribution Security under the Drug Supply Chain Security Act 1
Equivalence of Complex Products; Public Workshop 1
Food and Drug Administration Small Business and Industry Assistance Regulatory Education for Industry Spring Conference; Public Conference 1
Food and Drug Administration, Center for Drug Evaluation and Research Rare Diseases Public Workshop: Strategies, Tools, and Best Practices for Effective Advocacy in Rare Diseases Drug Development 1
Food and Drug Administration/Xavier University Medical Device Conference (MedCon) 1
Food and Drug Administration/Xavier University PharmaLink Conference--Leadership in a Global Supply Chain 1
Fostering Digital Health Innovation: Developing the Software Precertification Program; Public Workshop 1
Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee 1
Generic Drug User Fee Amendments of 2012; Regulatory Science Initiatives; Public Workshop 1
Identification and Characterization of Infectious Disease Risks of Human Cells, Tissues, and Cellular and Tissue-Based Products; Public Workshop; Correction 1
Joint Meeting of the Ophthalmic Devices Panel of the Medical Devices Advisory Committee and the Risk Communication Advisory Committee 1
Joint Public Consultation on International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use 1
Leveraging Quantitative Methods and Modeling to Modernize Generic Drug Development and Review; Public Workshop 1
Medical Gas Regulation; Public Workshops 1
Medical Imaging Drugs Advisory Committee 2
Neurological Devices Panel of the Medical Devices Advisory Committee 1
New Insights for Product Development and Bioequivalence Assessments of Generic Orally Inhaled and Nasal Drug Products; Public Workshop 1
Nonprescription Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee 1
Oncologic Drugs Advisory Committee 2
Oncologic Drugs Advisory Committee; Establishment of Public Docket 5
Oncology Center of Excellence Listening Session 1
Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee 1
Over-the-Counter Monograph User Fees 1
Packaging, Storage, and Disposal Options to Enhance Opioid Safety--Exploring the Path Forward; Public Workshop 1
Patient Engagement Advisory Committee 1
Patient Engagement Advisory Committee; Amendment 1
Patient-Focused Drug Development for Alopecia Areata 1
Patient-Focused Drug Development for Autism 1
Patient-Focused Drug Development for Hereditary Angioedema 1
Patient-Focused Drug Development for Sarcopenia; Correction 1
Patient-Focused Drug Development: Developing and Submitting Proposed Draft Guidance Relating to Patient Experience Data; Public Workshop 1
Patient-Focused Drug Development: Guidance 1--Collecting Comprehensive and Representative Input; Public Workshop 1
Pediatric Advisory Committee 2
Pediatric Advisory Committee, Pediatric Ethics Subcommittee 1
Pediatric Advisory Committee; Establishment of Public Docket; Request for Comments 1
Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee 1
Peripheral and Central Nervous System Drugs Advisory Committee; Establishment of Public Docket; Request for Comments 1
Pharmacy Compounding Advisory Committee 2
Preparation for International Cooperation on Cosmetics Regulation Eleventh Annual Meeting 1
Prescription Drug User Fee Act of 2017; Electronic Submissions and Data Standards 1
Psychopharmacologic Drugs Advisory Committee 1
Psychopharmacologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee 2
Reducing the Risk of Preventable Adverse Drug Events Associated With Hypoglycemia in the Older Population; Public Workshop 1
Roadmap for Engaging with Food and Drug Administration's Center for Drug Evaluation and Research; Public Workshop 1
Safe Use Symposium: A Focus on Reducing Preventable Harm from Drugs in the Outpatient Setting 1
Safety Assessment for Investigational New Drug Safety Reporting; Public Workshop 1
Safety Assessment for Investigational New Drug Safety Reporting; Public Workshop; Correction 1
Science Advisory Board to National Center for Toxicological Research Advisory Committee 1
Science Board to Food and Drug Administration Advisory Committee 1
Science Board to the Food and Drug Administration Advisory Committee 1
Second Annual Workshop on Clinical Outcome Assessments in Cancer Clinical Trials; Public Workshop 1
Self-Collection Devices for Pap Test; Public Workshop; Request for Comments 1
Sentinel Training; Public Workshop 1
Strategic Partnerships to Enhance Safety of Imported Foods: Capacity Building, Risk-Based Decisionmaking, Recognition of Commodity Food Control Programs, and Systems Recognition 1
Tenth Annual Sentinel Initiative; Public Workshop 1
Tobacco Products Scientific Advisory Committee 2
Topical Dermatological Generic Drug Products: Overcoming Barriers to Development and Improving Patient Access 1
Training Health Care Providers on Pain Management and Safe Use of Opioid Analgesics--Exploring Path Forward; Public Workshop 1
United States Food and Drug Administration and Health Canada Joint Regional Consultation on International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use 1
Vaccines and Related Biological Products Advisory Committee 6
Voluntary Medical Device Manufacturing and Product Quality Program 1
Voluntary Medical Device Manufacturing and Product Quality Program; Public Workshop 1
Weighing the Evidence: Variant Classification and Interpretation in Precision Oncology; Public Workshop 1

Modified Risk Tobacco Product Applications:

Modified Risk Tobacco Products; Applications:

New Animal Drugs:

Withdrawal of Approval of Application 1

New Drug Applications:

Barr Laboratories, Inc. et al.; Withdrawal of Approval 1
Bayer Healthcare Pharmaceuticals; BAYCOL (cerivastatin sodium) Tablets; Withdrawal of Approval 1
Department of Health and Human Services, Supply Service Center et al.; Withdrawal of Approval of 27 Abbreviated New Drug Applications 1
Department of Health and Human Services, Supply Service Center et al.; Withdrawal of Approval of 27 Abbreviated New Drug Applications; Correction 1
Guerbet Group; Withdrawal of Approval 1
Hospira, Inc. et al.; Withdrawal of Approval; Correction 1
Mepergan Fortis Capsules 1
Pre-Submission Facility Correspondence Associated with Priority Submissions; Draft Guidance for Industry; Availability 1
Roxane Laboratories, Inc.; Withdrawal of Approval 1
Upsher-Smith Laboratories, Inc.; Withdrawal of Approval for PROPRANOLOL HYDROCHLORIDE 1
Upsher-Smith Laboratories, Inc.; Withdrawal of Approval for ZALEPLON 1
Wyeth Pharmaceuticals Inc. et al.; Withdrawal of Approval 1

Outsourcing Facility Fee Rates for Fiscal Year 2018 1

Patent Extension Regulatory Review Periods:

Intercept Blood System for Plasma 1
Intercept Blood System for Platelets 1

Patent Infringement Complaints Filed Against a Biosimilar Applicant 3

Pediatric Postmarketing Pharmacovigilance and Drug Utilization Reviews 2

Pediatric Studies of Ampicillin Conducted in Accordance With the Public Health Service Act 1

Pilot Project Program under the Drug Supply Chain Security Act 1

Prescription Drug User Fee Act VI Commitment to Assess Current Practices of the Food and Drug Administration and Sponsors in Communicating During Investigational New Drug Development; Establishment of a Public Docket 1

Priority Review Vouchers:

Rare Pediatric Disease Product 4

Program for Enhanced Review Transparency and Communication for Original 351(k) Biologics License Applications in Biosimilar User Fee Act II 1

Public Dockets; Establishments:

Opioid Policy Steering Committee 1

Regulatory Review Period for Patent Extensions:

CINQAIR 1
VONVENDI 1

Regulatory Review Periods for Purposes of Patent Extensions:

REXULTI 1
SAVAYSA 1
SENZA SPINAL CORD STIMULATION SYSTEM 1
SOLX SYSTEM 1
VELTASSA 1
XURIDEN 1
YONDELIS 1
ZERBAXA 1

Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements and Commitments 1

Request for Comments:

Requests for Comments:

Accreditation Scheme for Conformity Assessment Pilot Program 1
Animal Drug User Fee Act; Recommendations; Extension of Comment Period 1
Animal Generic Drug User Fee Act; Recommendations; Extension of Comment Period 1
Tobacco Product Manufacturing Practice 1

Requests for Information:

Requests for Nominations:

Site Visit Training Program for Office of Pharmaceutical Quality Staff 1

Statements of Organization, Functions, and Delegations of Authority 2

Tribal Consultation Policy 1

Website Location of Center for Devices and Radiological Health Fiscal Year 2018 Proposed Guidance Development 1

Withdrawal of Approval of 7 New Drug Applications and 71 Abbreviated New Drug Applications:

Johnson and Johnson Consumer, Inc. et al. 1

Withdrawal of Approval of Three New Drug Applications and One Abbreviated New Drug Application; Correction:

B. Braun Medical, Inc.; 1

Withdrawal of New Drug Applications; Approvals:

B. Braun Medical, Inc. 1