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December 9, 2020

2018 Meeting Materials, Pharmaceutical Science and Clinical Pharmacology Advisory Committee

2018 Meeting Materials, Pharmaceutical Science and Clinical Pharmacology Advisory Committee | FDA In this section: Pharmaceutical Science and Clinical Pharmacology Advisory Committee Home Advisory Committees Committees […]
December 9, 2020

Remarks by Dr. Hahn for the Reagan-Udall Foundation’s Innovation in Regulatory Science Awards – 12/08/2020

Good evening.  Thank you, Ellen [Sigal] I’m delighted to be with you tonight for the Reagan-Udall Foundation’s presentation of its Innovations in Regulatory Science awards. There […]
December 8, 2020

Coronavirus (COVID-19) Update: December 8, 2020

For Immediate Release: December 08, 2020 The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 […]
December 8, 2020

CDER Small Business and Industry Assistance (SBIA) Learn

Drug Master File (DMF) and Drug Substance Workshop Webinar 3/3/2021 Drug Master Files OTC Monograph Reform in the CARES Act: Safety Orders Webinar 1/27/2021 OTC Drug […]
December 8, 2020

Information for Consumers and Patients | Drugs

Tainted Sexual Enhancement Products Approval, labeling, side effects, and safety Finding and Learning about Side Effects (adverse reactions) Approval, labeling, side effects, and safety Understanding the […]
December 8, 2020

Project Orbis: Strengthening International Collaboration for Oncology Product Reviews, Faster Patient Access to Innovative Therapies

Image By: Jeet Guram, M.D., Senior Advisor to the Commissioner, R. Angelo de Claro, M.D., Associate Director for Global Clinical Sciences (Acting) in the Oncology Center […]
December 8, 2020

High Blood Pressure–Understanding the Silent Killer

The Who, What, Why, and How of High Blood Pressure  Who is affected by high blood pressure? Approximately 1 in 3, nearly 70 million, American adults […]
December 8, 2020

2017 Meeting Materials, Oncologic Drugs Advisory Committee

2017 Meeting Materials, Oncologic Drugs Advisory Committee | FDA In this section: Oncologic Drugs Advisory Committee Home Advisory Committees Committees and Meeting Materials Human Drug Advisory […]
December 8, 2020

Best Practices in Developing Proprietary Names for Human Prescription Drug Products; Guidance for Industry

Docket Number: FDA-2014-D-0622 Issued by: Guidance Issuing Office Center for Biologics Evaluation and Research FDA is issuing this guidance to help sponsors of human prescription drug […]
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