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August 7, 2020

What’s New at CDER in HIV/AIDS

Get updates on safety and regulatory issues related to HIV/AIDS medical products such as: product approvals significant warnings safety warnings notices of upcoming public meetings notices […]
August 7, 2020

FDA approved changes to the DOVATO (dolutegravir/lamivudine) product labeling

FDA approved changes to the DOVATO (dolutegravir/lamivudine) product labeling to include a new indication and provide longer term (96 week) safety and efficacy data from the […]
August 6, 2020

FDA granted accelerated approval to belantamab mafodotin-blmf for multiple myeloma

On August 5, 2020, the Food and Drug Administration granted accelerated approval to belantamab mafodotin-blmf (Blenrep, GlaxoSmithKline) for adult patients with relapsed or refractory multiple myeloma […]
August 6, 2020

An Exciting New Chapter in OTC Drug History: OTC Monograph Reform in the CARES Act

Image By: Theresa M. Michele, M.D., Director, Office of Nonprescription Drugs, Center for Drug Evaluation and Research 240 million Americans use over-the-counter (OTC) drugs every year. […]
August 6, 2020

Drug Trial Snapshot: XEGLYZE

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 […]
August 6, 2020

Ferring US Issues Voluntary Nationwide Recall of DDAVP® Nasal Spray 10 mcg/0.1mL, Desmopressin Acetate Nasal Spray 10 mcg/0.1mL, STIMATE® Nasal Spray 1.5 mg/mL Due to Superpotency

Summary Company Announcement Date: August 05, 2020 FDA Publish Date: August 05, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Superpotency Company Name: Ferring […]
August 5, 2020

BIORESEARCH MONITORING TECHNICAL CONFORMANCE GUIDE

Issued by: Guidance Issuing Office Center for Drug Evaluation and Research This technical conformance guide, when finalized, will represent the current thinking of the Food and […]
August 5, 2020

Limited Population Pathway for Antibacterial and Antifungal Drugs – the LPAD Pathway

On December 13, 2016, the Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD pathway) was added to the Federal Food, Drug, and Cosmetic (FD&C) Act […]
August 5, 2020

Roque Plast S.A. de C.V. Issues Voluntary Nationwide Recall of Command Brands Gel AntiBac Instant Hand Sanitizer Lots 200371-12, 200371OH-05, 170420OH-06, 170420OH-8 Due to Potential Presence of Methanol (Wood Alcohol)

Summary Company Announcement Date: August 04, 2020 FDA Publish Date: August 04, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Methanol Contamination Company Name: […]
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