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FDA Denies Petition Seeking Accelerated Aging Therapies

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FDA denies an Age Reversal Unity petition asking the agency to establish a framework and issue guidance for expedited clinical tri...

Diasol Manufacturing Illegal Dialysis Disinfectants: FDA

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FDA warns Phoenix, AZ-based Diasol, Inc., about multiple Quality System and Medical Device Reporting violations in its illegal man...

BioMarin Natriuretic Peptide Petition Denied

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FDA denies a BioMarin petition asking it not to approve any C-type natriuretic peptides to treat achondroplasia until the expirati...

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

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

Chinese API Manufacturer Cited in FDA Form 483

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

Time to Update FDA SUPAC Guidances

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

New Guide on Drug 3-Year Exclusivity

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FDA posts a new draft guidance entitled New Clinical Investigation Exclusivity (3-Year Exclusivity) for Drug Products: Questions a...

30 Warning Letters to Telehealth Companies Over GLP-1 Marketing

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

ICH M14 Guide on Non-Interventional Study Principles Out

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

FDA Publishes ICH Postapproval Safety Data Guide

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