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Public Meeting on Drug Supply Chain Security

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Federal Register notice: FDA announces a 12/7-8 virtual public meeting entitled Drug Supply Chain Security Act Implementation and ...

Reject FDA Privilege Claim in FOIA Case: WLF

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Washington Legal Foundation says the DC Circuit federal court should grant summary judgment in favor of a Vanda Pharmaceuticals su...

RapidAIs Lastest Version of Rapid ICH Cleared

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FDA clears a RapidAI 510(k) for the latest release of Rapid ICH, an intracranial hemorrhage triage and notification product.

Panel Votes Down Veru Covid Therapy

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An FDA advisory committee votes 8 to 5 to recommend against an emergency use authorization for Verus investigational prostate canc...

Insulet Diabetes Manager Correction

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FDA says Insulet has issued a correction for its Omnipod DASH personal diabetes managers due to issues with the batteries.

EUA for Kineret to Treat Covid-19 in Some Adults

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FDA grants an emergency use authorization to Swedish Orphan Biovitrum for its Kineret to treat some adults hospitalized with Covid...

FDA Cancels Panel Meeting on GSKs Zejula

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Federal Register notice: FDA cancels an 11/22 Oncologic Drugs Advisory Committee meeting to discuss a GlaxoSmithKline supplemental...

NatureLab Adulterated and Misbranded Dietary Supplements

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FDA warns Carrollton, TX-based NatureLab about adulterated and mislabeled dietary supplements.

CGMP Violations at Abraxis Bioscience

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FDA warns Phoenix, AZ-based Abraxis Bioscience about CGMP violations in its manufacturing of finished pharmaceuticals.

ANDA Sameness Evaluation Guidance

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FDA publishes a draft guidance with recommendations on how ANDA applicants can demonstrate sameness between the active ingredient ...