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Ethicon Hemostatic Matrix Recall is Class 1

[ Price : $8.95]

FDA says an Ethicon recall of Surgiflo Hemostatic Matrix products due to a packing process issue is Class 1.

Guidance for Home Use Device Design

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FDA publishes a draft guidance to help manufacturers design and develop home use medical devices that minimize their unique risks.

Pfizer Pays $55 Million to Settle Protonix Off-label Activities

[ Price : $8.95]

Pfizer agrees to pay $55 million plus interest to resolve allegations that its Wyeth subsidiary illegally introduced into intersta...

Natus Medical Olympic Cool-Cap System Recall is Class 1

[ Price : $8.95]

FDA says the Natus Medical recall of the Olympic Cool-Cap System due to the potential for unexpected power failure and lack of coo...

Product Design Safety Consideration Draft Guidance Out

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FDA publishes a draft guidance to help drug sponsors minimize medication errors relating to drug product design.

Mylan Wants FDA to Deny Valeant Zovirax Petition

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Mylan calls on FDA to deny a Valeant petition asking that the agency require clinical endpoint studies for any ANDA for generic Zo...

Milo Biotech Orphan Status for Muscular Dystrophy Drug

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FDA grants Milo Biotechnology an orphan drug designation for AAV1-FS344 for treating Becker and Duchenne muscular dystrophy.

OMB OKs Info on Disease Info in Branded Promos

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Federal Register Notice: The Office of Management and Budget approves an FDA collection of information on an experimental study on...

Janssen Files NDA for Diabetes Combo Pill

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Janssen files an NDA seeking approval for a fixed-dose therapy combining canagliflozin and immediate-release metformin to treat pa...

Higher CV Risk Seen in Chantix Patients

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FDA says a higher occurrence of major adverse cardiovascular events was observed in patients using Pfizer's smoking cessation aid ...