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Webinar on Rx Drug Labeling Resources

[ Price : $8.95]

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

FDA Updates Web Page on Medtronic HeartWare Recalls

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

ORA Reorganization Notice Corrected

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

Zimmer Biomet New Persoa Tibis Cleared

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

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

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

Science Board to Discuss Cadmium Exposure

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

Gamida Cell BLA Review Extended by 3 Months

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

Philips Respironics Reports More Problems with Ventilators

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FDA asks for additional information from Philips Respironics after it reported two new potential issues with an ongoing recall of ...

Provention Bio Diabetes Delayer Approved

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FDA approves a Provention Bio BLA for Tzield (teplizumab-mzwv) injection and its use in delaying onset of Stage 3 Type 1 diabetes ...

Inspections Focusing on Management Responsibility: FDA

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FDA Office of Regulatory Affairs Division of Pharmaceutical Quality Operations III program director Jeffrey Meng tells an industry...