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FDA Cites ECR Pharmaceuticals TussiCaps Pro

[ Price : $8.95]

FDA cites Valeant Pharmaceuticals subsidiary ECR Pharmaceuticals for a professional sales aid for TussiCaps (hydrocodone polistire...

Thalidomide Protector Frances Kelsey Dies

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Former FDA medical reviewer Frances O. Kelsey, who prevented the thalidomide birth defect tragedy from occurring in the U.S., dies...

Cook Medical Recalls Contrast Dye Catheters

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Cook Medical begins a Class 1 recall of the Beacon Tip Torcon NB Advantage Catheters, Beacon Tip Royal Flush Plus High-Flow Cathet...

FDA Approves Upsher-Smiths Generic Namenda

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FDA approves an Upsher-Smith Laboratories ANDA for memantine HCl tablets in 5 mg and 10 mg strength, generic copies of Actavis Nam...

FDA Clears Flowonix Patient Therapy Controller

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FDA clears a Flowonix Medical 510(k) for the Patient Therapy Controller that is intended interface with the companys Prometra plat...

FDA Corrects Notice on Quality Metrics Guidance

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Federal Register Notice: FDA corrects a docket number in a 7/28 Federal Register notice.

12 Lawmakers Ask for GAO Probe into FDA Morcellator Role

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Twelve members of congress ask comptroller general Gene Dodaro for a GAO investigation into FDAs role in first clearing and then w...

Marina Biotech Gains Fast Track for FAP Therapy

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FDA grants Marina Biotech a fast track designation for CEQ508, an investigational RNAi therapeutic for treating familial adenomato...

Report Seeks FDA Cybersecurity Reforms to Block Hacking Threat

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In response to a cyber hacking attack in 2013, a new Congressional report recommends that FDA and other HHS agencies chief informa...

Momenta Opposes AbbVie Petition on Biosimilar Labeling

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Momenta says FDA should reject a recent AbbVie citizen petition that seeks to impose labeling requirements on biosimilar products ...