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Human Drugs

Monoclonal Antibody Potency Assay Guidance

FDA publishes a draft guidance with recommendations on assessing the potency of monoclonal antibodies and some other therapeutic proteins.

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Human Drugs

FDA Highlights Rare Disease Day 2023 with ARC

CDER associate director for rare diseases Kerry Jo Lee marks Rare Disease Day 2023 by highlighting the new Accelerate Rare disease Cures program.

Medical Devices

eSTAR Template Early Learnings: Regulation Expert

Hyman, Phelps & McNamara principal medical device regulation expert Adrienne Lenz describes early learnings from working with FDAs new eSTAR 510(k) su...

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Biologics

Cell/Gene Therapy Post-approval Safety Meeting

CBERs Office of Therapeutic Products announces a 4/27 public listening meeting to receive input on methods and approaches for capturing post-approval ...

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Biologics

Panel Backs GSK Vaccine for RSV in Older Adults

An advisory committee votes to recommend that safety and effectiveness data were adequate to support approval of GSKs vaccine Arexvy for preventing lo...

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Medical Devices

Warning on Getinge/Maquet Cardiohelp System

An FDA letter to healthcare professionals warns about potential insufficient packaging sterility with a disposable part of the Getinge/Maquet Cardiohe...

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Human Drugs

Cytokinetics Gets NDA Complete Response Letter

FDA sends Cytokinetics a complete response letter on its NDA for omecamtiv mecarbil, a cardiac myosin activator for treating heart failure with reduce...

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Federal Register

FDA Withdraws 11 No-Longer-Marketed ANDAs

Federal Register notice: FDA withdraws approval of 11 ANDAs because the drug products are no longer marketed.

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4 New CBER Standard Policies and Procedures

CBER issues four Standard Operating Policy and Procedure documents for staff handling of four types of CBER-regulated product submissions.

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FDA Restricting Unlawful Importing of Xylazine

FDA issues an import alert to restrict the unlawful importation of the veterinary drug xylazine that has been found in illicit fentanyl and other drug...