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October 22, 2020

Drug Trials Snapshots: INMAZEB

HOW TO USE THIS SNAPSHOTThe information provided in Snapshots highlights who participated in the clinical trials that supported the FDA approval of this drug, and whether […]
October 22, 2020

Wholesale Distributor Verification Requirement for Saleable Returned Drug Product and Dispenser Verification Requirements When Investigating a Suspect or Illegitimate Product—Compliance Policies

Docket Number: FDA-2019-D-4212. Issued by: Guidance Issuing Office Center for Biologics Evaluation and Research Office of Regulatory Affairs Center for Drug Evaluation and Research On September […]
October 22, 2020

Model-Informed Drug Development Pilot Program

As displayed in the Federal Register notice on April 16, 2018, the FDA is conducting a Model-Informed Drug Development (MIDD) Pilot Program to facilitate the development and […]
October 22, 2020

Dr. Reddy’s Confirms its Voluntary Nationwide Recall of All Ranitidine Products in the U.S. Market

Summary Company Announcement Date: October 23, 2019 FDA Publish Date: October 23, 2019 Product Type: Drugs Reason for Announcement: Recall Reason Description Contains N-Nitrosodimethylamine (NDMA) Company […]
October 22, 2020

GDUFA III Reauthorization Negotiation Sessions

In accordance with the Federal Food, Drug, and Cosmetic Act (FD&C Act), the Food and Drug Administration (FDA) held negotiations with the generic drug industry on […]
October 21, 2020

Regulatory Pharmaceutical Fellowship

The US Food and Drug Administration (FDA) partners with universities and colleges of pharmacy in the United States to offer FDA-affiliated fellowship programs to Doctor of […]
October 21, 2020

Advisory Committees Give FDA Critical Advice and the Public a Voice

Image Español At the U.S. Food and Drug Administration, we rely on our many advisory committees to help us make sound decisions based on the best […]
October 20, 2020

Coronavirus (COVID-19) Update: Daily Roundup October 20, 2020

For Immediate Release: October 20, 2020 The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 […]
October 20, 2020

Cooperative Manufacturing Arrangements for Licensed Biologics

Docket Number: FDA-1999-D-0128 Issued by: Guidance Issuing Office Center for Biologics Evaluation and Research Center for Drug Evaluation and Research The development of complex and highly […]
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