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Human Drugs

FDA Working on Peptide Accessibility: Politico

Politico reports that HHS secretary Robert F. Kennedy Jr. said FDA will soon approve a way to make some peptides more accessible to the public.

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Human Drugs

Vanda Wins Long-Sought Hearing on Hetlioz sNDA for Jet Lag

FDA grants Vanda Pharmaceuticals a long-sought formal evidentiary public hearing to review the agencys proposal to refuse approval of a supplemental N...

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Human Drugs

Chinese API Manufacturer Cited in FDA Form 483

FDA cites Chinese active pharmaceutical ingredient manufacturer Hubei JXBio Pharmaceutical Co for multiple deficiencies in its handling of deviations ...

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Human Drugs

Time to Update FDA SUPAC Guidances

FDA seeks public input on whether to revise a longstanding series of manufacturing guidance documents that govern how drugmakers manage postapproval c...

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Human Drugs

New Guide on Drug 3-Year Exclusivity

FDA posts a new draft guidance entitled New Clinical Investigation Exclusivity (3-Year Exclusivity) for Drug Products: Questions and Answers.

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Human Drugs

30 Warning Letters to Telehealth Companies Over GLP-1 Marketing

FDA sends 30 Warning Letters to telehealth companies for making false or misleading claims about compounded GLP-1 medications on their Web sites.

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Human Drugs

ICH M14 Guide on Non-Interventional Study Principles Out

FDA publishes the International Council for Harmonization M14 guidance on planning, designing, analyzing, and reporting non-interventional studies usi...

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Human Drugs

FDA Publishes ICH Postapproval Safety Data Guide

FDA publishes the International Council for Harmonization E2D(R1) guidance on management and reporting of postapproval individual case safety reports.

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Human Drugs

Fukuzyu FDA-483 Out

FDA posts the form FDA-483 issued following a 2024 inspection at Japans Fukuzyu Pharmaceutical Co.

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Human Drugs

FDA Hits Novo Nordisk Over Ozempic Ad

FDA cites a Novo Nordisk direct-to-consumer advertisement for its blockbuster diabetes drug Ozempic (semaglutide), calling the ad misleading and viola...