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Docket Established for Opioid Disposal

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Federal Register notice: FDA creates a docket to solicit public comments on a potential modification to its Opioid Analgesic Risk ...

Annual Report on Postmarketing Commitments

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Federal Register notice: FDA makes available an annual report entitled Report on the Performance of Drug and Biologics Firms in Co...

FDA OKs Production at Kite CAR T-Cell Facility

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FDA approves commercial production at a new Kite CAR T-cell manufacturing facility in Maryland.

3 Philips Ventilator Recalls Class 1

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FDA says recalls of the Philips Respironics V60, V60 Plus, and V680 Plus ventilators are Class 1.

Modifications to Device Recognized Standards

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Federal Register notice: FDA announces modifications to its list of standards the agency recognizes for use in premarket reviews.

Breakthrough Granted to Donor Heart Transport Device

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FDA grants Bridge to Life a breakthrough device designation for its LifeCradle Heart Preservation Transport System, intended to pr...

NAC Product Enforcement Discretion Guidance

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FDA publishes a draft guidance explaining its enforcement discretion for dietary supplements containing N-acetyl-L-cysteine.

Covid Vaccine for Kids Under 5 May Come in June: NBC

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NBC News reports FDA may authorize Covid vaccinations for children under age 5 in June.

Nanomaterial Drug, Biologic Product Guidance

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FDA issues a finalized guidance on developing human drug products that contain nanomaterials.

Glaxo NDA Accepted for Anemia Drug

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FDA accepts a GlaxoSmithKline NDA for daprodustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor for treating pati...