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April 8, 2020

Pregnancy, Lactation, and Reproductive Potential: Labeling for Human Prescription Drug and Biological Products-Content and Format

Docket Number: FDA-2014-D-1551 Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research Office of Medical Products and Tobacco, […]
April 8, 2020

Pre-Launch Activities Importation Requests (PLAIR)

Docket Number: FDA-2013-D-0836 Issued by: Guidance Issuing Office Office of the Commissioner                                           Submit Comments You can submit online or written comments on any guidance at […]
April 8, 2020

Pregnancy, Lactation, and Reproductive Potential: Labeling for Human Prescription Drug and Biological Products — Content and Format Guidance for Industry (Small Entity Compliance Guide)

Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research Office of Medical Products and Tobacco, Center for Biologics […]
April 8, 2020

Potassium Iodide as a Thyroid Blocking Agent in Radiation Emergencies

Docket Number: FDA-2000-D-1403 Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research The objective of this document is […]
April 8, 2020

Postmarketing Studies and Clinical Trials—Implementation of Section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act Guidance for Industry

Docket Number: FDA-2009-D-0283 Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research Office of Medical Products and Tobacco, […]
April 8, 2020

Postmarketing Studies and Clinical Trials — Implementation of Section 505(O)(3) of the Federal Food, Drug, and Cosmetic Act

Docket Number: FDA-2009-D-0283 Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research Office of Medical Products and Tobacco, […]
April 7, 2020

How do I request a Patient Listening Session?

Thank you for your interest in requesting a Patient Listening Session! The information on this page is also available as a 2-page PDF that can be […]
April 7, 2020

Compounding Activities | COVID-19

FDA is working to provide guidance to states and compounders on issues associated with compounding drugs during the COVID-19 pandemic. The agency’s guidance aims to protect […]
April 7, 2020

Hand Sanitizers | COVID-19

On this page Making Hand Sanitizers Available to Americans FDA plays a critical role in protecting the United States from emerging infectious diseases, such as the […]
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