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FDA Warns 2 Firms Selling Supplements with Tianeptine

[ Price : $8.95]

FDA warns two companies selling dietary supplements containing tianeptine.

Beckman Coulter Cytometer Recall is Class 1

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FDA classifies as Class 1 a Beckman Coulter recall of two models of flow cytometers due to an electrical circuit error.

SIG Medical 510(k) Cleared for AdvantageRib Anterior System

[ Price : $8.95]

FDA clears a SIG Medical 510(k) for its AdvantageRib Anterior System, intended for the fixation, stabilization, and fusion of rib ...

47 Drugs Listed Not Withdrawn Due to Safety/Efficacy

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Federal Register notice: FDA determines that 47 drug products it is listing were not withdrawn from sale for reasons of safety or ...

FDA Meeting to Address Drug Shortages

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FDA and Duke-Margolis Health Policy Center plan an 11/27 public meeting to seek stakeholder input on long-term solutions to addres...

FDA Approval Expands Label for Novartis Promacta

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FDA approves an expanded label for Novartis Promacta (eltrombopag) to include first-line treatment for adults and pediatric patien...

Safety Alert on Pharm D Solutions Products

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FDA alerts health care professionals and patients not to use drug products produced and distributed by Pharm D Solutions (Houston,...

Qualified Claim on Coronary Heart Disease for Oils

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FDA responds to a petition to allow a new qualified health claim for edible oils containing high levels of oleic acid, a monounsat...

Info Collection Extension for Biosimilar Applications

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Federal Register notice: FDA submits to OMB an information collection extension for General Licensing Provisions; Section 351(k) B...

FDA Turns Down Generic Tadalafil Oral Film

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FDA issues Aquestive Therapeutics a complete response letter on its NDA tadalafil oral film, a PDE5 inhibitor currently marketed (...