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Public Citizen Wants Plavix Boxed Warning

[ Price : $8.95]

Public Citizen petitions FDA for a Boxed Warning on Plavix labeling about risk of potentially fatal bleeding after more than 12 mo...

CHPA Wants Acetaminophen Labeled for Kids

[ Price : $8.95]

CHPA asks for an FDA statement of enforcement discretion allowing companies to label childrens OTC acetaminophen products with dos...

FDA Approves Yeast, Bacteria Testing System

[ Price : $8.95]

FDA approves marketing of bioMerieux Vitek MS for mass spectrometry identification of 193 bacteria and yeasts.

Nuvo Research Sues Mallinckrodt for $100 Million

[ Price : $8.95]

Nuvo Research files a lawsuit against Mallinckrodt asserting that the company has breached its contractual obligations under a 200...

FDA Using 3-D Printing to Further Regulatory Science

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CDRH Office of Science and Engineering Laboratories director Steven Pollack blogs about his organizations use of 3-D printing to f...

FDA Clears Reverse Medical Vascular Plug

[ Price : $8.95]

FDA clears a Reverse Medical 510(k) for the MVP Micro Vascular Plug system for peripheral artery embolization.

FDA Clears Novo Nordisks NovoPen Echo

[ Price : $8.95]

FDA clears a Novo Nordisk 510(k) for its insulin delivery device NovoPen Echo.

CDER Issues ANDA Suitability MAPP

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CDER issues a MAPP spelling out roles to be played in a response coordinated by the Office of Generic Drugs to ANDA suitability pe...

Petition Asks FDA Action on Lovaza Strength Designation

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A Crowell Moring petition says FDA has all the information it needs to approve a request to change the Lovaza strength listing in ...

Meeting on FDA/EMA Orphan Product/HUD Programs

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Federal Register Notice: FDA will hold a meeting 10/4 on FDA/EMA orphan drug designation programs, the FDA humanitarian use device...