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Revisit Third-party Device Reviews: Pilot

[ Price : $8.95]

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

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...

Hospira Troubles May Lead to Consent Decree, Analyst Says

[ Price : $8.95]

RBC Capital Markets analyst Shibani Malhotra says it is looking more likely that a consent decree will be needed to ensure GMP vio...

FDA Appeals Cigarette Graphic Warnings Injunction

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FDA files a notice to appeal a federal court order granting a preliminary injunction to delay requirements for cigarette makers to...

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Crescendo Therapeutics, Hills Pet Nutrition, Nanoliposomals, Osmed, and Precisio...

FDA Approves Watsons Generic Yaz

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FDA approves a Watson Laboratories ANDA for a generic version of Bayers Yaz oral contraceptive.

Osmed Warned About QS Violations

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FDA warns Osmed GmbH about Quality System and other violations in its manufacturing of a tissue expander.

Post-marketing Violations at Crescendo

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FDAs Los Angeles District Office warns Crescendo Therapeutics of post-marketing adverse drug experience and unapproved new drug vi...

FDA Will Review a BMS/Pfizer NDA for Eliquis

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FDA has accepted for review a Bristol-Myers Squibb/Pfizer NDA for Eliquis for preventing stroke and systemic embolism in atrial fi...

BioTime, OncoCyte Add Former FDA Commish to Boards

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BioTime and subsidiary OncoCyte appoint former FDA commissioner Andrew von Eschenbach to their boards of directors.