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FDA Vaccines/Related Biologicals Panel Renewal

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Federal Register notice: FDA renews for two years its Vaccines and Related Biological Products Advisory Committee charter.

FDA Testing Results Posted on NDMA in Metformin

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FDA posts laboratory results showing N- Nitrosodimethylamine levels in some metformin products.

Priority Vouchers Do Little for Development: GAO

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A new Government Accountability Office report on FDAs priority review voucher program finds that they have had little or no effect...

FDA/FTC Curbing False Biological/Biosimilar Promos

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FDA and FTC agree to crack down on anti-competitive practices, such as making false or misleading statements comparing biological ...

FDA Clears Qynapse Brain Analysis Software

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FDA clears a Qynapse 510(k) for its QyScore software that analyzes brain MRI markers that occur early in diseases such as Alzheime...

Boston Scientific Safety Notice on Ablation System

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Boston Scientific issues an urgent field safety notice about installing a firmware update for its Maestro 4000 Cardiac Ablation Sy...

GW Pharma sNDA for Cannabidiol Product

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GW Pharmaceuticals submits a supplemental NDA for Epidiolex (cannabidiol) oral solution for an expanded use to include seizures as...

DC Judge Rules for FDA in Vanda Clinical Hold

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A DC federal judge sides with FDA in a Vanda Pharmaceuticals lawsuit that sought to remove a partial clinical hold the agency impo...

Latest Federal Register Notices

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FDA Review posts the Federal Register notices for the week ending 1/31/2020.

Guide on Retroviral Vector-Based Gene Therapies

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Federal Register notice: FDA makes available a final guidance on testing retroviral vector-based human gene therapy products.