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October 23, 2020

Foothills Professional Pharmacy, LTD – 598883 – 09/09/2020

Delivery Method: Via Email Product: Drugs Recipient: Recipient Name Mr. Pujan A. Patel Recipient Title Owner Foothills Professional Pharmacy, LTD 4545 E. Chandler Blvd., Suite 100Phoenix, […]
October 22, 2020

FDA Approves First Treatment for COVID-19

For Immediate Release: October 22, 2020 Español Today, the U.S. Food and Drug Administration approved the antiviral drug Veklury (remdesivir) for use in adult and pediatric […]
October 22, 2020

FDA’s approval of Veklury (remdesivir) for the treatment of COVID-19—The Science of Safety and Effectiveness

[10/22/2020] FDA recognizes that patients affected by coronavirus 2019 (COVID-19) are in great need of medicines to treat this disease. To help meet this need, the […]
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 […]
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