Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability

by the Food and Drug Administration on 07/14/2017.

The Food and Drug Administration (FDA or Agency) is announcing the availability of additional draft and revised draft product-specific guidances. The guidances, when finalized, provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs). In the...

New Animal Drugs; Withdrawal of Approval of a New Animal Drug Application

by the Food and Drug Administration on 07/12/2017.

The Food and Drug Administration (FDA) is withdrawing approval of two new animal drug applications (NADAs). This action is being taken at the sponsor's request because these products are no longer manufactured or marketed.

Determination of Regulatory Review Period for Purposes of Patent Extension; Intercept Blood System for Plasma

by the Food and Drug Administration on 07/11/2017.

The Food and Drug Administration (FDA) has determined the regulatory review period for INTERCEPT BLOOD SYSTEM FOR PLASMA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of...

Medical Devices; Exemptions From Premarket Notification: Class II Devices

by the Food and Drug Administration on 07/11/2017.

The Food and Drug Administration (FDA or Agency) is announcing a list of class II devices that the Agency has determined based on established factors to no longer require premarket notification to provide reasonable assurance of safety and effectiveness, subject to certain limitations. FDA is publishing this notice of that determination in...

Determination of Regulatory Review Period for Purposes of Patent Extension; Intercept Blood System for Platelets

by the Food and Drug Administration on 07/11/2017.

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for Intercept Blood System for Platelets and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO),...

Draft Standardization of Pharmaceutical Quality/Chemistry Manufacturing and Control Data Elements and Terminologies; Request for Comments

by the Food and Drug Administration on 07/11/2017.

The Food and Drug Administration (FDA or Agency) is requesting comment on the draft standardized Pharmaceutical Quality/Chemistry Manufacturing and Control (PQ/CMC) data elements and terminologies for the electronic submission of PQ/CMC data. The establishment of standardized pharmaceutical quality data elements and terminologies will provide...

Arthritis Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments

by the Food and Drug Administration on 07/10/2017.

The Food and Drug Administration (FDA or Agency) announces a forthcoming public advisory committee meeting of the Arthritis Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public...

Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection of Zika Virus; Availability; Correction

by the Food and Drug Administration on 07/10/2017.

The Food and Drug Administration is correcting a notice entitled ``Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection of Zika Virus; Availability'' that appeared in the Federal Register of June 30, 2017 (82 FR 29886). The document announced the issuance of two Emergency Use Authorizations for in vitro diagnostic devices...

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

by the Food and Drug Administration on 07/03/2017.

The Food and Drug Administration (FDA) is correcting a document that appeared in the Federal Register of Thursday, April 6, 2017 (82 FR 16733). That notification published three waivers from the Requirements of 21 CFR part 1, subpart O--Sanitary Transportation of Human and Animal Food (the Sanitary Transportation rule). That document was...

Food Labeling; Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments; Extension of Comment Period

by the Food and Drug Administration on 07/03/2017.

The Food and Drug Administration (FDA or we) is extending the comment period for the interim final rule that appeared in the Federal Register of May 4, 2017. In the interim final rule, FDA requested comments on the extension of the compliance date for our final rule requiring disclosure of certain nutrition information for standard menu items in...

Listing of Color Additives Exempt From Certification; Spirulina Extract

by the Food and Drug Administration on 07/03/2017.

The Food and Drug Administration (FDA or we) is amending the color additive regulations to provide for the expanded safe use of spirulina extract to seasonally color hard-boiled shell eggs at levels consistent with good manufacturing practice (GMP). This action is in response to a color additive petition (CAP) filed by McCormick & Company, Inc....

Product Identifier Requirements Under the Drug Supply Chain Security Act-Compliance Policy; Draft Guidance for Industry; Availability

by the Food and Drug Administration on 07/03/2017.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Product Identifier Requirements Under the Drug Supply Chain Security Act-- Compliance Policy.'' This draft guidance describes FDA's intention with regard to enforcement of requirements related to product identifiers under...

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food and Drug Administration Safety Communication Readership Survey

by the Food and Drug Administration on 07/03/2017.

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

Advisory Committee; Medical Imaging Drugs Advisory Committee, Renewal

by the Food and Drug Administration on 07/03/2017.

The Food and Drug Administration (FDA) is announcing the renewal of the Medical Imaging Drugs Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Medical Imaging Drugs Advisory Committee for an additional 2 years beyond the charter expiration...

Agency Information Collection Activities; Proposed Collection; Comment Request; Food Safety Survey

by the Food and Drug Administration on 07/03/2017.

The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including...

Advisory Committees; Filing of Closed Meeting Reports

by the Food and Drug Administration on 07/03/2017.

The Food and Drug Administration (FDA) is announcing that, as required by the Federal Advisory Committee Act, the Agency has filed with the Library of Congress the annual reports of those FDA advisory committees that held closed meetings during fiscal year 2016.

Joint Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments

by the Food and Drug Administration on 07/03/2017.

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee. The general function of the committees is to provide advice and recommendations to the Agency on FDA's regulatory issues. At...

Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals

by the Food and Drug Administration on 07/03/2017.

The Food and Drug Administration (FDA) is publishing a list of information collections that have been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

Authorization of Emergency Use of an Injectable Treatment for Nerve Agent or Certain Insecticide (Organophosphorus and/or Carbamate) Poisoning; Availability

by the Food and Drug Administration on 06/30/2017.

The Food and Drug Administration (FDA) is announcing the issuance of an Emergency Use Authorization (EUA) (the Authorization) for an injectable treatment for nerve agent or certain insecticide (organophosphorus and/or carbamate) poisoning. FDA issued this Authorization under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as requested...

Agency Information Collection Activities: Proposed Collection; Comment Request; Applications for Food and Drug Administration Approval To Market a New Drug

by the Food and Drug Administration on 06/30/2017.