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3 New Device Guides for Performance-Based Pathway

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FDA posts three new guidances for device makers to use under its Safety and Performance-Based Pathway.

Notice Corrected on Drug Development Tools Guide

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Federal Register notice: FDA corrects an 11/25 notice entitled Qualification Process for Drug Development Tools; Guidance for Indu...

FDA Withdraws 10 No-Longer-Marketed ANDAs

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Federal Register notice: FDA is withdrawing approval of 10 ANDAs from multiple applicants after they notified the agency that the ...

Comments Extended on Electromagnetic Compatibility Guide

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Federal Register notice: FDA extends the comment period on a draft guidance entitled Electromagnetic Compatibility of Medical Devi...

Bone, Reproductive/Urologic Drugs Panel Renewed

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Federal Register notice: FDA announces the renewal of its Bone, Reproductive and Urologic Drugs Advisory Committee for an addition...

Lexicon Pharma Fast Track for Neuropathic Pain

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FDA grants Lexicon Pharmaceuticals a fast track designation for LX9211 and its use in treating diabetic peripheral neuropathic pai...

Sanofi/GSK Delay Covid Vaccine Over Disappointing Data

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Sanofi and GlaxoSmithKline delay their Covid-19 vaccine program to improve immune response in older adults.

Covid-19 Vaccine EUA Granted Amid White House Pressure

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FDA grants an emergency use authorization for Pfizer-BioNTechs Covid-19 vaccine amid a White House threat for commissioner Stephen...

FDA Withdrawing Approval of Allergans Asacol

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Federal Register notice: FDA withdraws the approval of an Allergan Pharmaceuticals International NDA for Asacol (mesalamine) delay...

FDA Performance Review Board Members Announced

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Federal Register notice: FDA announces the names of the members who will serve on its fiscal year 2020 Performance Review Board.