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FDA Overhauls National Drug Codes

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FDA finalizes a sweeping overhaul of the National Drug Code system, adopting a standardized 12-digit format for the identifier use...

Partial Hold on Myotonic Dystrophy Type 1 Therapy

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FDA places a partial clinical hold on a mid-stage U.S. trial of PepGen Inc.s experimental therapy for myotonic dystrophy Type 1.

FDA Posts Fujian Genohope FDA-483

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FDA posts the form FDA-483 with six observations from a 2023 inspection at the Fujian Genohope Biotech sterile drug manufacturing ...

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FDA posts a new draft guidance entitled New Clinical Investigation Exclusivity (3-Year Exclusivity) for Drug Products: Questions a...