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Workshop on Device Postmarket Surveillance Registries

[ Price : $8.95]

Federal Register Notice: FDA plans a public workshop 9/12-13: Leveraging Registries with Medical Device Data for Postmarket Survei...

Workshop on Mass Casualty Burn Injuries

[ Price : $8.95]

Federal Register Notice: FDA plans a public workshop 9/27-28, Medical Countermeasures (MCM) for a Burn Mass Casualty Incident.

Workshop on Device Postmarket Surveillance

[ Price : $8.95]

Federal Register Notice: FDA will hold a public meeting 9/10, Public Meeting Strengthening the National Medical Device Postmarket...

Panel to Discuss OTC Switch for Overactive Bladder Treatment

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Federal Register Notice: FDAs Nonprescription Drugs Advisory Committee will meet 11/9 to discuss a partial OTC switch for MSD Cons...

GOP Pledges FDA Reforms

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The Republican platform pledges unspecified FDA reforms directed at keeping innovation and jobs in this country.

Janssen Paying $181 Million for Deceptive Ads

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Janssen agrees to pay $181 million to resolve deceptive advertising charges for its Risperdal and Invega filed by 37 states and Wa...

B. Braun Wants Hospira Lactated Ringers as RLD

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B. Braun asks FDA to designate Hospiras lactated ringers as the reference-listed drug.

Simplifying Drug Protein Production

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A University of Arkansas chemical engineering researcher says she has developed a technique that will save drug companies time and...

Orphan Status for Narcolepsy Investigational Drug

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FDA grants Aerial BioPharma an orphan drug designation for ARL-N05 and its use in treating narcolepsy.

FDA Clears Crospon EndoFlip for Gastro Uses

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FDA clears a Crospon 510(k) for its EndoFLIP system and its use in gastroenterology applications.