{"description":"Documents matching 'clinical compliance'","count":9194,"total_pages":50,"next_page_url":"https://www.federalregister.gov/api/v1/documents?conditions%5Bterm%5D=clinical+compliance&format=json&page=2","results":[{"title":"Announcement of the Approval of COLA as an Accreditation Organization for the Specialties of Clinical Cytogenetics and Radiobioassay Under the Clinical Laboratory Improvement Amendments of 1988","type":"Notice","abstract":"This notice announces the application of the Commission on Laboratory Accreditation (COLA) for approval as an accreditation organization for clinical laboratories under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) program for the specialties of Clinical Cytogenetics and Radiobioassay. We have determined that COLA meets or exceeds the applicable CLIA requirements. Consequently, we are granting COLA deeming authority for the specialties of Clinical Cytogenetics and Radiobioassay for a period of 5 years.","document_number":"2025-23434","html_url":"https://www.federalregister.gov/documents/2025/12/19/2025-23434/announcement-of-the-approval-of-cola-as-an-accreditation-organization-for-the-specialties-of","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-12-19/pdf/2025-23434.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-23434.pdf?1766065524","publication_date":"2025-12-19","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Centers for Medicare & Medicaid Services","name":"Centers for Medicare & Medicaid Services","id":45,"url":"https://www.federalregister.gov/agencies/centers-for-medicare-medicaid-services","json_url":"https://www.federalregister.gov/api/v1/agencies/45","parent_id":221,"slug":"centers-for-medicare-medicaid-services"}],"excerpts":"application of the Commission on Laboratory Accreditation (COLA) for approval as an accreditation organization for <span class=\"match\">clinical</span> laboratories under the <span class=\"match\">Clinical</span> Laboratory Improvement Amendments of 1988 (CLIA) program for the specialties of <span class=\"match\">Clinical</span> Cytogenetics and Radiobioassay. We have determined that COLA meets or exceeds the applicable CLIA requirements. Consequently, we are granting COLA deeming authority for the specialties of <span class=\"match\">Clinical</span> Cytogenetics and Radiobioassay for a period of 5 years. \n \n \n DATES: \n This notice is applicable from January 20"},{"title":"Proposed Collection; 60-Day Comment Request; Application and Impact of Clinical Research Training on Healthcare Professionals in Academia and Clinical Research (Office of the Director)","type":"Notice","abstract":"In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the Office of Clinical Research Education and Collaboration Outreach (OCRECO), Office of Intramural Research (OIR), National Institutes of Health, will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.","document_number":"2025-21913","html_url":"https://www.federalregister.gov/documents/2025/12/04/2025-21913/proposed-collection-60-day-comment-request-application-and-impact-of-clinical-research-training-on","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-12-04/pdf/2025-21913.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-21913.pdf?1764769513","publication_date":"2025-12-04","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"National Institutes of Health","name":"National Institutes of Health","id":353,"url":"https://www.federalregister.gov/agencies/national-institutes-of-health","json_url":"https://www.federalregister.gov/api/v1/agencies/353","parent_id":221,"slug":"national-institutes-of-health"}],"excerpts":"two generic/template surveys for additional courses as part of the <span class=\"match\">clinical</span> research education programs of the office. The <span class=\"match\">clinical</span> research education programs include: the Introduction to the Principles and Practice of <span class=\"match\">Clinical</span> Research and Principles of <span class=\"match\">Clinical</span> Pharmacology, Sabbatical in <span class=\"match\">Clinical</span> Research Management, the NIH Summer Course in <span class=\"match\">Clinical</span> and Translational Research, the Ethical and Regulatory Aspects of <span class=\"match\">Clinical</span> Research Course (Asynchronous/Online), the <span class=\"match\">Clinical</span> Research Curriculum Certificate Program, the Radiology Research Certificate"},{"title":"Psychedelic Drugs: Considerations for Clinical Investigations; Guidance for Industry; Availability","type":"Notice","abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry titled \"Psychedelic Drugs: Considerations for Clinical Investigations.\" Because interest in the therapeutic potential of psychedelic drugs has been increasing and designing clinical trials to evaluate these compounds presents unique challenges, FDA developed the draft guidance to present foundational aspects for sponsors to consider. This final guidance provides general considerations for sponsors developing psychedelic drugs for the treatment of medical conditions (e.g., psychiatric disorders, substance use disorders) and discusses recommendations for clinical investigations psychedelic drugs. This guidance finalizes the draft guidance of the same title issued on June 26, 2023.","document_number":"2026-14158","html_url":"https://www.federalregister.gov/documents/2026/07/14/2026-14158/psychedelic-drugs-considerations-for-clinical-investigations-guidance-for-industry-availability","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-07-14/pdf/2026-14158.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-14158.pdf?1783946717","publication_date":"2026-07-14","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"Considerations for <span class=\"match\">Clinical</span> Investigations.” Because interest in the therapeutic potential of psychedelic drugs has been increasing and designing <span class=\"match\">clinical</span> trials to evaluate these compounds presents unique challenges, FDA developed the draft guidance to present foundational aspects for sponsors to consider. This final guidance provides general considerations for sponsors developing psychedelic drugs for the treatment of medical conditions (\n e.g., \n psychiatric disorders, substance use disorders) and discusses recommendations for <span class=\"match\">clinical</span> investigations"},{"title":"Use of Bayesian Methodology in Clinical Trials of Drug and Biological Products; Draft Guidance for Industry; Availability","type":"Notice","abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled \"Use of Bayesian Methodology in Clinical Trials of Drug and Biological Products.\" This document provides guidance on the appropriate use of Bayesian methods in clinical trials. The primary focus is on the use of Bayesian methods to support primary inference in pivotal clinical trials designed to support the effectiveness and safety of drug and biological products.","document_number":"2026-00325","html_url":"https://www.federalregister.gov/documents/2026/01/12/2026-00325/use-of-bayesian-methodology-in-clinical-trials-of-drug-and-biological-products-draft-guidance-for","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-01-12/pdf/2026-00325.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-00325.pdf?1767966312","publication_date":"2026-01-12","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Use of Bayesian Methodology in <span class=\"match\">Clinical</span> Trials of Drug and Biological Products.” This document provides guidance on the appropriate use of Bayesian methods in <span class=\"match\">clinical</span> trials. The primary focus is on the use of Bayesian methods to support primary inference in pivotal <span class=\"match\">clinical</span> trials designed to support the effectiveness and safety of drug and biological products. \n \n \n DATES: \n Submit either electronic or written comments on the"},{"title":"M11 Clinical Electronic Structured Harmonised Protocol (CeSHarP); International Council for Harmonisation; Guidance for Industry; Availability","type":"Notice","abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled \"M11 Clinical Electronic Structured Harmonised Protocol (CeSHarP).\" The guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The guidance includes three documents: a guidance, a template, and a technical specification document. The guidance provides the rationale and recommendations for implementing a harmonized digital clinical trial protocol. The template features standardized content structure and formatting, including headers and common text elements. The technical specification document contains harmonized terminologies and standardized data fields to enable electronic exchange of clinical protocol information. The intent of the guidance is to create an internationally harmonized standard for the content and exchange of clinical trial protocol information, facilitating the review and assessment by regulators, sponsors, ethical oversight bodies, investigators, and other stakeholders. This guidance finalizes the draft guidances \"M11 Clinical Electronic Structured Harmonised Protocol (CeSHarP)\" issued on December 22, 2022 (87 FR 78696), and \"M11 Technical Specification: Clinical Electronic Structured Harmonised Protocol\" issued on June 6, 2025 (90 FR 24146).","document_number":"2026-10295","html_url":"https://www.federalregister.gov/documents/2026/05/22/2026-10295/m11-clinical-electronic-structured-harmonised-protocol-cesharp-international-council-for","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-05-22/pdf/2026-10295.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-10295.pdf?1779367514","publication_date":"2026-05-22","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"electronic exchange of <span class=\"match\">clinical</span> protocol information. The intent of the guidance is to create an internationally harmonized standard for the content and exchange of <span class=\"match\">clinical</span> trial protocol information, facilitating the review and assessment by regulators, sponsors, ethical oversight bodies, investigators, and other stakeholders. This guidance finalizes the draft guidances “M11 <span class=\"match\">Clinical</span> Electronic Structured Harmonised Protocol (CeSHarP)” issued on December 22, 2022 (87 FR 78696), and “M11 Technical Specification: <span class=\"match\">Clinical</span> Electronic Structured Harmonised"},{"title":"E6(R3) Good Clinical Practice; International Council for Harmonisation; Guidance for Industry; Availability","type":"Notice","abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled \"E6(R3) Good Clinical Practice.\" The guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The guidance includes a principles document and annex 1 and is the precursory guidance to the draft guidance entitled \"E6(R3) Good Clinical Practice: Annex 2.\" Once complete, the guidance will be composed of a principles document, annex 1, and annex 2. The guidance is intended to outline flexible and modern good clinical practices for conducting clinical trials. Notably, the guidance highlights the importance of quality-by-design, proportionality, and risk-based approaches in conducting clinical trials to ensure safety and reliability of results. The guidance also encourages use of innovative design elements and technology in clinical trials, while avoiding unnecessary complexities. The guidance finalizes the draft guidance of the same title issued on June 7, 2023.","document_number":"2025-17311","html_url":"https://www.federalregister.gov/documents/2025/09/09/2025-17311/e6r3-good-clinical-practice-international-council-for-harmonisation-guidance-for-industry","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-09-09/pdf/2025-17311.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-17311.pdf?1757335516","publication_date":"2025-09-09","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"“E6(R3) Good <span class=\"match\">Clinical</span> Practice.” The guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The guidance includes a principles document and annex 1 and is the precursory guidance to the draft guidance entitled “E6(R3) Good <span class=\"match\">Clinical</span> Practice: Annex 2.” Once complete, the guidance will be composed of a principles document, annex 1, and annex 2. The guidance is intended to outline flexible and modern good <span class=\"match\">clinical</span> practices for conducting <span class=\"match\">clinical</span> trials."},{"title":"Announcement of the Approval of COLA as an Accreditation Organization for the Specialty of Histocompatibility Under the Clinical Laboratory Improvement Amendments of 1988","type":"Notice","abstract":"This notice announces the application of the Commission on Laboratory Accreditation (COLA) for approval as an accreditation organization for clinical laboratories under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) program for the specialty of Histocompatibility. We have determined that COLA meets or exceeds the applicable CLIA requirements. Consequently, we are granting COLA deeming authority for the specialty of Histocompatibility for a period of 5 years.","document_number":"2026-11618","html_url":"https://www.federalregister.gov/documents/2026/06/10/2026-11618/announcement-of-the-approval-of-cola-as-an-accreditation-organization-for-the-specialty-of","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-06-10/pdf/2026-11618.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-11618.pdf?1781009114","publication_date":"2026-06-10","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Centers for Medicare & Medicaid Services","name":"Centers for Medicare & Medicaid Services","id":45,"url":"https://www.federalregister.gov/agencies/centers-for-medicare-medicaid-services","json_url":"https://www.federalregister.gov/api/v1/agencies/45","parent_id":221,"slug":"centers-for-medicare-medicaid-services"}],"excerpts":"ACTION: \n Notice. \n \n \n SUMMARY: \n This notice announces the application of the Commission on Laboratory Accreditation (COLA) for approval as an accreditation organization for <span class=\"match\">clinical</span> laboratories under the <span class=\"match\">Clinical</span> Laboratory Improvement Amendments of 1988 (CLIA) program for the specialty of Histocompatibility. We have determined that COLA meets or exceeds the applicable CLIA requirements. Consequently, we are granting COLA deeming authority for the specialty of Histocompatibility for a period of 5 years. \n \n \n DATES: \n This notice is applicable"},{"title":"E20 Adaptive Designs for Clinical Trials; International Council for Harmonisation; Draft Guidance for Industry; Availability","type":"Notice","abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled \"E20 Adaptive Designs for Clinical Trials.\" The draft guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The draft guidance is intended to provide a transparent and harmonized set of recommendations for clinical trials with an adaptive design. The draft guidance focuses on principles for the planning, conduct, analysis, and interpretation of clinical trials with an adaptive design that aim to confirm the efficacy and support the benefit-risk assessment of a treatment. The draft guidance emphasizes principles that are critical for ensuring clinical trials produce reliable and interpretable results and that involve specific considerations with use of an adaptive design.","document_number":"2025-18897","html_url":"https://www.federalregister.gov/documents/2025/09/30/2025-18897/e20-adaptive-designs-for-clinical-trials-international-council-for-harmonisation-draft-guidance-for","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-09-30/pdf/2025-18897.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-18897.pdf?1759149909","publication_date":"2025-09-30","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"draft guidance for industry entitled “E20 Adaptive Designs for <span class=\"match\">Clinical</span> Trials.” The draft guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The draft guidance is intended to provide a transparent and harmonized set of recommendations for <span class=\"match\">clinical</span> trials with an adaptive design. The draft guidance focuses on principles for the planning, conduct, analysis, and interpretation of <span class=\"match\">clinical</span> trials with an adaptive design that aim to confirm the efficacy"},{"title":"TRICARE Coverage of Clinical Trials and Termination of Expanded Access Treatments","type":"Rule","abstract":"The Assistant Secretary of Defense for Health Affairs (ASD(HA)) issues this final rule regarding circumstances under which services and supplies related to emerging treatments may be covered under the TRICARE program. This rule finalizes provisions published in two interim final rules (IFRs) with request for comment, which temporarily added coverage for the treatment use of investigational drugs under U.S. Food and Drug Administration (FDA)-authorized expanded access (EA) programs when for the treatment of coronavirus disease 2019 (COVID-19) and permitted coverage of National Institute of Allergy and Infectious Disease (NIAID)-sponsored clinical trials for the treatment or prevention of COVID-19. This final rule discusses the DoD's decision not to make permanent the coverage of treatment use of investigational drugs under FDA EA programs while updating language for care associated with their administration and broadens the COVID-19 clinical trial benefit to include coverage of clinical trials sponsored or approved by any National Institutes of Health (NIH) Center or Institute to treat or prevent infectious diseases associated with a pandemic or epidemic. Lastly, the final rule expands TRICARE's clinical trial benefit by covering services and supplies provided in conjunction with Phase I, II, III, and IV clinical trials that are NIH-sponsored or approved and that involve a new treatment or cure for a specific condition or the treatment of a currently uncontrolled symptom or aspect of that condition, provided that the condition is severely debilitating, life- threatening, or a rare disease.","document_number":"2025-14206","html_url":"https://www.federalregister.gov/documents/2025/07/28/2025-14206/tricare-coverage-of-clinical-trials-and-termination-of-expanded-access-treatments","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-07-28/pdf/2025-14206.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-14206.pdf?1753447522","publication_date":"2025-07-28","agencies":[{"raw_name":"DEPARTMENT OF DEFENSE","name":"Defense Department","id":103,"url":"https://www.federalregister.gov/agencies/defense-department","json_url":"https://www.federalregister.gov/api/v1/agencies/103","parent_id":null,"slug":"defense-department"},{"raw_name":"Office of the Secretary"}],"excerpts":"Disease 2019 <span class=\"match\">Clinical</span> Trials,” which discussed temporary coverage of NIAID-sponsored <span class=\"match\">clinical</span> trials for the treatment of COVID-19, published in the \n Federal Register \n on October 30, 2020 (85 FR 68753-68758). Comments were accepted for 30 days, and the DoD received four comments. The DoD thanks all commenters for their submissions. In the COVID-19 <span class=\"match\">Clinical</span> Trials IFR, the DoD specifically solicited comments on the potential expansion of TRICARE's <span class=\"match\">clinical</span> trial benefit beyond cancer <span class=\"match\">clinical</span> trials and NIAID-sponsored COVID-19 <span class=\"match\">clinical</span> trials. Two"},{"title":"Innovative Designs for Clinical Trials of Cellular and Gene Therapy Products in Small Populations; Draft Guidance for Industry; Availability","type":"Notice","abstract":"The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a draft document entitled \"Innovative Designs for Clinical Trials of Cellular and Gene Therapy Products in Small Populations.\" The draft guidance document provides recommendations to sponsors who are planning clinical trials of cell and gene therapy (CGT) products intended for use in a disease or condition that affects a small population, generally one that meets the definition of a rare disease or condition under section 526(a)(2) of the FD&C Act (21 U.S.C. 360bb(a)(2)). It describes FDA requirements and provides considerations for the use of various clinical trial designs and endpoints to generate clinical evidence to support product licensure. The recommendations are intended for sponsors developing CGTs intended for use in small populations to leverage the use of innovative trial designs to simultaneously expedite drug development and generate data necessary to demonstrate substantial evidence of effectiveness.","document_number":"2025-18651","html_url":"https://www.federalregister.gov/documents/2025/09/25/2025-18651/innovative-designs-for-clinical-trials-of-cellular-and-gene-therapy-products-in-small-populations","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-09-25/pdf/2025-18651.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-18651.pdf?1758717925","publication_date":"2025-09-25","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"“Innovative Designs for <span class=\"match\">Clinical</span> Trials of Cellular and Gene Therapy Products in Small Populations.” The draft guidance document provides recommendations to sponsors who are planning <span class=\"match\">clinical</span> trials of cell and gene therapy (CGT) products intended for use in a disease or condition that affects a small population, generally one that meets the definition of a rare disease or condition under section 526(a)(2) of the FD&amp;C Act (21 U.S.C. 360bb(a)(2)). It describes FDA requirements and provides considerations for the use of various \n \n <span class=\"match\">clinical</span> trial designs"},{"title":"Approaches to Assessment of Overall Survival in Oncology Clinical Trials; Draft Guidance for Industry; Availability","type":"Notice","abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled \"Approaches to Assessment of Overall Survival in Oncology Clinical Trials.\" The purpose of this draft guidance is to provide recommendations to sponsors on the assessment of overall survival in randomized oncology clinical trials conducted to support marketing approval of drugs and biological products, with an emphasis on the analysis of overall survival as a prespecified safety endpoint. While the draft guidance discusses situations in which it is appropriate to consider overall survival for the primary endpoint, this draft guidance primarily focuses on statistical or design considerations when overall survival is not the primary endpoint.","document_number":"2025-15796","html_url":"https://www.federalregister.gov/documents/2025/08/19/2025-15796/approaches-to-assessment-of-overall-survival-in-oncology-clinical-trials-draft-guidance-for-industry","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-08-19/pdf/2025-15796.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-15796.pdf?1755521132","publication_date":"2025-08-19","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"guidance for industry entitled “Approaches to Assessment of Overall Survival in Oncology <span class=\"match\">Clinical</span> Trials.” The purpose of this draft guidance is to provide recommendations to sponsors on the assessment of overall survival in randomized oncology <span class=\"match\">clinical</span> trials conducted to support marketing approval of drugs and biological products, with an emphasis on the analysis of overall survival as a prespecified safety endpoint. Overall survival is an objective, <span class=\"match\">clinically</span> meaningful endpoint that can be measured easily and precisely. It is considered a gold"},{"title":"Oncology Therapeutic Radiopharmaceuticals: Dosage Optimization During Clinical Development; Draft Guidance for Industry; Availability","type":"Notice","abstract":"The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled \"Oncology Therapeutic Radiopharmaceuticals: Dosage Optimization During Clinical Development.\" This guidance is intended to assist sponsors in identifying an optimized dosage for radiopharmaceutical therapies (RPT) for oncology indications during clinical development and prior to submitting a marketing application for a new indication and usage. The guidance provides considerations for RPT dosage optimization in RPT development programs.","document_number":"2025-15797","html_url":"https://www.federalregister.gov/documents/2025/08/19/2025-15797/oncology-therapeutic-radiopharmaceuticals-dosage-optimization-during-clinical-development-draft","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-08-19/pdf/2025-15797.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-15797.pdf?1755521132","publication_date":"2025-08-19","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled “Oncology Therapeutic Radiopharmaceuticals: Dosage Optimization During <span class=\"match\">Clinical</span> Development.” This guidance is intended to assist sponsors in identifying an optimized dosage for radiopharmaceutical therapies (RPT) for oncology indications during <span class=\"match\">clinical</span> development and prior to submitting a marketing application for a new indication and usage. The guidance provides considerations for RPT dosage optimization in RPT development programs"},{"title":"Submission for OMB Review; 30-Day Comment Request Application and Impact of Clinical Research Training on Healthcare Professionals in Academia and Clinical Research (Office of the Director)","type":"Notice","abstract":"In compliance with the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below.","document_number":"2026-08461","html_url":"https://www.federalregister.gov/documents/2026/04/30/2026-08461/submission-for-omb-review-30-day-comment-request-application-and-impact-of-clinical-research","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-04-30/pdf/2026-08461.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-08461.pdf?1777466720","publication_date":"2026-04-30","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"National Institutes of Health","name":"National Institutes of Health","id":353,"url":"https://www.federalregister.gov/agencies/national-institutes-of-health","json_url":"https://www.federalregister.gov/api/v1/agencies/353","parent_id":221,"slug":"national-institutes-of-health"}],"excerpts":"Collection: \n Application and Impact of <span class=\"match\">Clinical</span> Research Training on Healthcare Professionals in Academia and <span class=\"match\">Clinical</span> Research, 0925-0764-expiration date, 07/31/2027, Revision, Office of <span class=\"match\">Clinical</span> Research Education and Collaboration Outreach (OCRECO), National Institutes of Health (NIH), Office of the Director (OD).\n \n \n Need and Use of Information Collection: \n The purpose of this survey is to assess the long-term impact and outcomes of <span class=\"match\">clinical</span> research training programs provided by the Office of <span class=\"match\">Clinical</span> Research Education and Collaboration Outreach"},{"title":"E21 Inclusion of Pregnant and Breastfeeding Women in Clinical Trials; International Council for Harmonisation; Draft Guidance for Industry; Availability","type":"Notice","abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled \"E21 Inclusion of Pregnant and Breastfeeding Women in Clinical Trials.\" The draft guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The draft guidance is intended to provide general principles on the conduct of clinical trials that include pregnant and breastfeeding women to inform evidence-based decisions on safe and effective use of medicinal products by these populations. The draft guidance includes approaches to generating data that support informed decision-making on the safety, dosing, and efficacy of medicinal products during pregnancy and breastfeeding. Additionally, the draft guidance includes recommendations for recruiting and retaining pregnant and breastfeeding women in clinical trials, while reducing burden and harm on these participants.","document_number":"2025-13680","html_url":"https://www.federalregister.gov/documents/2025/07/21/2025-13680/e21-inclusion-of-pregnant-and-breastfeeding-women-in-clinical-trials-international-council-for","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-07-21/pdf/2025-13680.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-13680.pdf?1752842718","publication_date":"2025-07-21","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"draft guidance outlines strategies and considerations for developing and implementing <span class=\"match\">clinical</span> studies that include pregnant or breastfeeding women. This draft guidance includes approaches to plan, collect data, evaluate outcomes, and monitor safety of pregnant and breastfeeding women participating in <span class=\"match\">clinical</span> trials safely and ethically. Additionally, the draft guidance includes recommendations for recruiting and retaining pregnant and breastfeeding women in <span class=\"match\">clinical</span> trials. The draft guidance also emphasizes reduction of burden on pregnant and breastfeeding"},{"title":"New Clinical Investigation Exclusivity (3-Year Exclusivity) for Drug Products: Questions and Answers; Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request","type":"Notice","abstract":"The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled \"New Clinical Investigation Exclusivity (3-Year Exclusivity) for Drug Products: Questions and Answers.\" This draft guidance is intended to assist applicants requesting New Clinical Investigation exclusivity (also referred to as 3-year exclusivity) for a new drug application (NDA) or NDA supplement. The guidance discusses the statutory and regulatory criteria for eligibility for 3-year exclusivity and provides recommendations on the content and format of requests for 3-year exclusivity in the form of questions and answers (Q&As). FDA intends to update this draft guidance document to include additional Q&As as appropriate.","document_number":"2026-04291","html_url":"https://www.federalregister.gov/documents/2026/03/04/2026-04291/new-clinical-investigation-exclusivity-3-year-exclusivity-for-drug-products-questions-and-answers","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-03-04/pdf/2026-04291.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-04291.pdf?1772545524","publication_date":"2026-03-04","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"claiming eligibility for 3-year exclusivity must provide certain information to show that the NDA contains “new <span class=\"match\">clinical</span> investigations” that are “essential to approval of the NDA or supplement” and were “conducted or sponsored by the applicant,” including a certification required by 21 CFR 314.50(j)(4)(i) that “to the best of the applicant's knowledge each of the <span class=\"match\">clinical</span> investigations included in the NDA meets the definition of `new <span class=\"match\">clinical</span> investigation' set forth in § 314.108(a).” The elements listed in that section are included in the template"},{"title":"List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act","type":"Notice","abstract":"The Food and Drug Administration (FDA, the Agency, or we) is evaluating substances that have been nominated for inclusion on a list of bulk drug substances (active pharmaceutical ingredients) for which there is a clinical need for outsourcing facilities to use in compounding (the 503B Bulks List). This notice identifies three bulk drug substances that FDA has considered and proposes not to include on the 503B Bulks List: semaglutide, tirzepatide, and liraglutide. Additional bulk drug substances nominated for inclusion on this list are under consideration and may be the subject of future notices.","document_number":"2026-08552","html_url":"https://www.federalregister.gov/documents/2026/05/01/2026-08552/list-of-bulk-drug-substances-for-which-there-is-a-clinical-need-under-section-503b-of-the-federal","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-05-01/pdf/2026-08552.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-08552.pdf?1777553125","publication_date":"2026-05-01","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"finalize a modification to the proposal to reflect new evidence or analysis regarding <span class=\"match\">clinical</span> need. FDA intends to then publish in the \n Federal Register \n a final determination identifying the bulk drug substances for which we have determined there is a <span class=\"match\">clinical</span> need and our rationale in making that final determination. FDA also intends to publish a final determination in the \n Federal Register \n for those substances which we considered but found that there is no <span class=\"match\">clinical</span> need to use in compounding and our rationale in making this decision.\n \n \n \n 11"},{"title":"M11 Technical Specification: Clinical Electronic Structured Harmonised Protocol; International Council for Harmonisation; Draft Technical Specification; and Template; Availability","type":"Notice","abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of the revised draft technical specification entitled \"M11 Technical Specification: Clinical Electronic Structured Harmonised Protocol (CeSHarP)\" and a supplemental document entitled \"M11 Template.\" The revised draft technical specification and template were prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The revised draft technical specification recommends the use of an open, nonproprietary standard to enable electronic exchange of clinical protocol information. The template identifies headers, common text, and a set of data fields and terminologies that will be the basis for efficiencies in data exchange. These ICH documents create an international standard for the content and exchange of clinical trial protocol information facilitating review and assessment by regulators, sponsors, ethical oversight bodies, investigators, and other stakeholders. This revised draft technical specification and updated template revise and replace the draft versions of the same titles issued in December 2022.","document_number":"2025-10359","html_url":"https://www.federalregister.gov/documents/2025/06/06/2025-10359/m11-technical-specification-clinical-electronic-structured-harmonised-protocol-international-council","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-06-06/pdf/2025-10359.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-10359.pdf?1749127521","publication_date":"2025-06-06","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"entitled “M11 Technical Specification: <span class=\"match\">Clinical</span> Electronic Structured Harmonised Protocol (CeSHarP)” and the supplemental document entitled “M11 Template” that were issued on December 22, 2022 (87 FR 78696), along with the draft guidance for industry entitled “M11 <span class=\"match\">Clinical</span> Electronic Structured Harmonised Protocol (CeSHarP)” (available at \n https://www.fda.gov/media/164112/download \n ).\n \n \n The technical specification recommends the use of an open, nonproprietary standard to enable electronic exchange of <span class=\"match\">clinical</span> protocol information. Revisions to"},{"title":"Study of Sex Differences in the Clinical Evaluation of Medical Products; Draft Guidance for Industry; Availability","type":"Notice","abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled \"Study of Sex Differences in the Clinical Evaluation of Medical Products.\" Clinical trials and non-interventional studies of medical products should be designed to enroll sufficient numbers of females and males to reflect the prevalence of the disease or condition for which the medical product is being investigated to help ensure the generalizability of results and facilitate exploration of potential differences in effects by sex. This guidance provides recommendations for increasing enrollment of females in clinical trials, analyzing and interpreting sex-specific data, and including sex-specific information in regulatory submissions of medical products. When finalized, this guidance will replace the guidance entitled \"Guideline for the Study and Evaluation of Gender Differences in the Clinical Evaluation of Drugs\" issued in July 1993.","document_number":"2024-31537","html_url":"https://www.federalregister.gov/documents/2025/01/07/2024-31537/study-of-sex-differences-in-the-clinical-evaluation-of-medical-products-draft-guidance-for-industry","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-01-07/pdf/2024-31537.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-31537.pdf?1736171122","publication_date":"2025-01-07","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"“Study of Sex Differences in the <span class=\"match\">Clinical</span> Evaluation of Medical Products.” <span class=\"match\">Clinical</span> trials and non-interventional studies of medical products should be designed to enroll sufficient numbers of females and males to reflect the prevalence of the disease or condition for which the medical product is being investigated to help ensure the generalizability of results and facilitate exploration of potential differences in effects by sex. This guidance provides recommendations for increasing enrollment of females in <span class=\"match\">clinical</span> trials, analyzing and interpreting"},{"title":"Proposed Collection: 30-Day Comment Request; The Clinical Trials Reporting Program (CTRP) Database (NCI)","type":"Notice","abstract":"In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide an opportunity for public comment on proposed data collection projects, the National Institutes of Health, National Cancer Institute (NCI) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.","document_number":"2026-05937","html_url":"https://www.federalregister.gov/documents/2026/03/27/2026-05937/proposed-collection-30-day-comment-request-the-clinical-trials-reporting-program-ctrp-database-nci","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-03-27/pdf/2026-05937.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-05937.pdf?1774529107","publication_date":"2026-03-27","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"National Institutes of Health","name":"National Institutes of Health","id":353,"url":"https://www.federalregister.gov/agencies/national-institutes-of-health","json_url":"https://www.federalregister.gov/api/v1/agencies/353","parent_id":221,"slug":"national-institutes-of-health"}],"excerpts":"Trials Reporting Program (CTRP) is an electronic resource that serves as a single, definitive source of information about all NCI-supported <span class=\"match\">clinical</span> research. This resource allows the NCI to consolidate reporting, aggregate data, and reduce redundant submissions. <span class=\"match\">Clinical</span> research administrators submit information as designees of <span class=\"match\">clinical</span> investigators who conduct NCI-supported <span class=\"match\">clinical</span> research. The designees can electronically access the CTRP website to complete the initial trial registration. After registration, three amendments and four study subject"},{"title":"Proposed Collection: 30-Day Comment Request; The Clinical Trials Reporting Program (CTRP) Database (NCI)","type":"Notice","abstract":"In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide an opportunity for public comment on proposed data collection projects, the National Institutes of Health, National Cancer Institute (NCI) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.","document_number":"2026-03709","html_url":"https://www.federalregister.gov/documents/2026/02/25/2026-03709/proposed-collection-30-day-comment-request-the-clinical-trials-reporting-program-ctrp-database-nci","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-02-25/pdf/2026-03709.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-03709.pdf?1771940708","publication_date":"2026-02-25","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"National Institutes of Health","name":"National Institutes of Health","id":353,"url":"https://www.federalregister.gov/agencies/national-institutes-of-health","json_url":"https://www.federalregister.gov/api/v1/agencies/353","parent_id":221,"slug":"national-institutes-of-health"}],"excerpts":"Reporting Program (CTRP) is an electronic resource that serves as a single, definitive source of information about all NCI-supported <span class=\"match\">clinical</span> research. This resource allows the NCI to consolidate reporting, aggregate data, and reduce redundant submissions. <span class=\"match\">Clinical</span> research administrators submit information as designees of <span class=\"match\">clinical</span> investigators who conduct NCI-supported <span class=\"match\">clinical</span> research. The designees can electronically access the CTRP website to complete the initial trial registration. After registration, four amendments and four study subject accrual"}]}