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April 21, 2020

Adverse Event Reporting for Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act

Docket Number: FDA-2014-D-2138 Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research This guidance is intended for firms […]
April 21, 2020

Advancement of Emerging Technology Applications for Pharmaceutical Innovation and Modernization Guidance for Industry

Docket Number: FDA-2015-D-4644 Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research This guidance provides recommendations to pharmaceutical […]
April 21, 2020

Advanced Prostate Cancer: Developing Gonadotropin-Releasing Hormone Analogues Guidance for Industry

Docket Number: FDA-2019-D-2808 Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research This guidance describes the Food and […]
April 21, 2020

Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biologics with Continuous Outcomes Guidance for Industry

Docket Number: FDA-2019-D-0934 Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research This draft guidance, when finalized, will […]
April 21, 2020

Adaptive Design Clinical Trials for Drugs and Biologics Guidance for Industry

Docket Number: FDA-2018-D-3124 Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Biologics Evaluation and Research Office of Medical Products and Tobacco, […]
April 21, 2020

General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products Guidance for Industry

Docket Number: FDA-2016-D-0785 Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research This guidance is intended to assist […]
April 21, 2020

General Clinical Pharmacology Considerations for Pediatric Studies for Drugs and Biological Products

Docket Number: FDA-2013-D-1275 Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research This draft guidance is intended to […]
April 21, 2020

General Clinical Pharmacology Considerations for Neonatal Studies for Drugs and Biological Products Guidance for Industry

Docket Number: FDA-2019-D-3132 Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research This draft guidance is intended to […]
April 21, 2020

Activities Report of the Generic Drugs Program | GDUFA II Quarterly Performance

In section VI(C)(2) of the Generic Drug User Fee Amendments Reauthorization for Fiscal Years 2018-2022 (GDUFA II Commitment Letter), FDA committed to publishing quarterly metrics on […]
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