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Federal Register

Guide on Compounding Beta-Lactam Products

Federal Register notice: FDA makes available a final guidance entitled Compounding Certain Beta-Lactam Products in Shortage Under Section 503A of the ...

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Medical Devices

Latest Philips Respironics MDRs

FDA reports on the latest three months of medical device reports on some Philips Respironics ventilators, BiPAP, and CPAP machines.

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Human Drugs

New Hemophilia B Gene Therapy Approved

FDA approves Behrings Hemgenix to treat some adults with Hemophilia B.

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Human Drugs

Webinar on Rx Drug Labeling Resources

FDA announces a 1/26/2023 Webinar entitled FDAs Labeling Resources for Human Prescription Drugs that will discuss new resources available for the phar...

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Medical Devices

FDA Updates Web Page on Medtronic HeartWare Recalls

FDA updates a Web page it maintains on Medtronic recalls involving its HeartWare Ventricular Assist Device system that is intended to enhance user acc...

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Federal Register

ORA Reorganization Notice Corrected

Federal Register notice: FDA corrects a 9/28 notice entitled Statement of Organization, Functions, and Delegations of Authority that discussed a reorg...

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Medical Devices

Zimmer Biomet New Persoa Tibis Cleared

FDA clears a Zimmer Biomet 510(k) for the Persona OsseoTi Keel Tibia for cementless knee replacement.

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Human Drugs

FDA OKs Jazz sBLA for Mon./Wed./Fri. Rylaze Dosing

FDA has approved a Jazz Pharmaceuticals supplemental BLA to add a Monday/Wednesday/Friday intramuscular dosing schedule for Rylaze (asparaginase erwin...

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Federal Register

Science Board to Discuss Cadmium Exposure

Federal Register notice: FDA announces a 12/8 Science Board to the FDA Advisory Committee meeting that will hear research needs for evaluating oral ca...

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Biologics

Gamida Cell BLA Review Extended by 3 Months

FDA extends by three months the review of a Gamida Cell BLA for omidubicel for treating patients with blood cancers in need of an allogenic hematopoie...