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FDA Approves 3 Boston Scientific Defibrillators

[ Price : $8.95]

FDA approves three Boston Scientific cardiac resynchronization and implantable cardioverter defibrillators.

Study Urges Multiple-dose Bio Studies for Generics

[ Price : $8.95]

A study article in the International Journal of Pharmaceutics argues for FDA to require multiple-dose bioequivalence studies like ...

Limited Evidence on Hip Implant Bearing Effectiveness: Study

[ Price : $8.95]

CDRH and university researchers find no evidence favoring one type of hip implant bearing over another.

FDA Approves Limits on Oxycodone ABUKs

[ Price : $8.95]

FDA grants part of a Lehigh Technologies/Glenmark Generics citizen petition seeking an upper limits on the presence of ABUK impuri...

Mumps Outbreaks Not Related to Mutant Virus Strains

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CBER scientists say recent mumps outbreaks are related to decreased immune response in young adults who were vaccinated as childre...

FDA Clears Abbott 510(k) for 25-OH Vitamin D Assay

[ Price : $8.95]

FDA clears an Abbott 510(k) for a fully-automated 25-OH Vitamin D assay performed on its Architect laboratory testing platform.

FDA Approves St. Jude Defibrillator, Lead

[ Price : $8.95]

FDA approves St. Jude Medicals Unify Quadra defibrillator and Quartet left ventricular lead.

Perrigo Challenges FDA on Bioequivalence of OTC Switch Drugs

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Perrigo says FDA should rescind receipt of any ANDA proposing a generic form of its Prevacid 24HR by relying on bioequivalence dat...

Ethicon, CDRH Reach Agreement on Sedasys Dispute

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Ethicon says it has reached an agreement with CDRH to settle an appeal of a not approvable letter for the company's Sedasys system...

Revisit Third-party Device Reviews: Pilot

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Noted Washington medical device lawyer Larry Pilot says its time to revisit the idea of third-party device reviews because CDRH ca...