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Gottlieb Wants to Stay at FDA

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FDA commissioner Scott Gottlieb says he believes he can most effectively serve the Trump administration as FDA commissioner rather...

Janssen Files NDA for Prostate Cancer Drug

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Janssen Biotech files an NDA for apalutamide, an investigational, next-generation oral androgen receptor inhibitor for men with no...

Philips to Halt Defibrillator Manufacturing Under Consent Decree

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Philips North America agrees to a consent decree with FDA that will see the company suspending external defibrillator manufacturin...

CMC Guidance Clarifications Sought

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Stakeholders ask for additional clarification and changes in an FDA draft guidance on CMC postapproval manufacturing changes for s...

Opioid Abuse Study Contracts Awarded

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CDERs Judy Staffa says the agency has awarded two contracts to organizations to help it better determine how well abuse-deterrent ...

Malin Appoints von Eschenbach as Chief Medical Adviser

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Malin Corp. appoints former FDA commissioner Andrew von Eschenbach as the companys chief medical advisor.

Draft Guide on Developing RSV Drugs

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FDA posts a draft guidance of Respiratory Syncytial Virus (RSV) Infection: Developing Antiviral Drugs for Prophylaxis and Treatmen...

St. Jude Recalls Unify Defibrillators Over Battery Issue

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St. Jude Medical recalls Unify and Unify Assura cardiac resynchronization therapy defibrillators due to battery issues.

QS and MDR Violations at Swedens Euro Diagnostica

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FDA warns Swedens Euro Diagnostica about Quality System and Medical Device Reporting violations in its manufacturing of Class 2 me...

QS Violations in Diasol Inspection

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FDA warns Diasol about QS violations in its New Jersey manufacturing and repacking facility.