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Monoclonal Antibody Potency Assay Guidance

[ Price : $8.95]

FDA publishes a draft guidance with recommendations on assessing the potency of monoclonal antibodies and some other therapeutic p...

FDA Highlights Rare Disease Day 2023 with ARC

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

eSTAR Template Early Learnings: Regulation Expert

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Hyman, Phelps & McNamara principal medical device regulation expert Adrienne Lenz describes early learnings from working with FDAs...

Cell/Gene Therapy Post-approval Safety Meeting

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

Panel Backs GSK Vaccine for RSV in Older Adults

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An advisory committee votes to recommend that safety and effectiveness data were adequate to support approval of GSKs vaccine Arex...

Warning on Getinge/Maquet Cardiohelp System

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An FDA letter to healthcare professionals warns about potential insufficient packaging sterility with a disposable part of the Get...

Cytokinetics Gets NDA Complete Response Letter

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

FDA Withdraws 11 No-Longer-Marketed ANDAs

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

4 New CBER Standard Policies and Procedures

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

FDA Restricting Unlawful Importing of Xylazine

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