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Fusion IV Recalls Sterile Drug Products

[ Price : $8.95]

Fusion IV Pharmaceuticals (dba Axia Pharmaceutical) recalls all unused sterile drug products within expiry due to a lack of steril...

House Members Seek FDA Info on Complex Generics

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Bipartisan House Energy and Commerce Committee ask FDA to provide information on the agencys approval performance on complex gener...

Ozempic OKd for Reducing Major Cardio Events

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FDA approves a new indication for Novo Nordisks Ozempic (semaglutide) injection 0.5 mg or 1 mg reducing the risk of major adverse...

Can a Name Misbrand a Drug? FDA Study

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FDA seeks comments on new proposed research by CDERs Office of Prescription Drug Promotion on promotional implications of propriet...

ANI Pharma Gains ANDA OK for Potassium Citrate

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FDA approves an ANI Pharmaceuticals ANDA for potassium citrate extended-release tablets USP, 10 mEq and 15 mEq.

TG Therapeutics Rolling NDA for Lymphoma Drug

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TG Therapeutics begins a rolling NDA submission for umbralisib, a dual inhibitor of PI3K-delta and CK1-epsilon for treating patien...

Info Collection Extension for BLA Licensing Provsions

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Federal Register notice: FDA submits to OMB an information collection extension for BLA general licensing provisions.

FDA Electronic Product Certification Program Explained

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CDRH electrical engineer Lowell Howard explains in a CDRH Learn video how manufacturers and importers can comply with the FDA elec...

Workshop on Medical Extended Reality Devices

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FDA sets a 3/5 public workshop entitled Medical Extended Reality: Toward Best Evaluation Practices for Virtual and Augmented Reali...

Mindbreeze Works with Booz Allen on CDER Project

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Mindbreeze says it is working with Booz Allen to give CDER regulatory review search capabilities.