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Bumpus Named Chief Scientific Officer at Charles River Labs

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Charles River Laboratories names former FDA principal deputy commissioner Namandj N. Bumpus as senior vice president and chief sci...

Expanded Use Cleared for Robotic Cochlear Implant Insertion

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FDA clears an iotaMotion 510(k) for an expanded pediatric indication for its iotaSOFT robotic-assisted cochlear implant insertion ...

FDA Hits Altor Bio Over Promo Violations

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FDA sends an untitled letter to Altor BioScience, alleging that promotional Web pages for bladder cancer drug Anktiva are false or...

FDA, EMA Drug Development AI Principles

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FDA and the European Medicines Agency publish their collaborative 10 guiding principles for using artificial intelligence in drug ...

Multiple Violations Seen in ASP Global Inspection

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FDA warns Austell, GA-based Anatomy Supply Partners about multiple types of violations in its manufacturing of the Safe-T-Fill Mic...

Sclerotic FDA Shuns Innovation: Column

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Taxpayers Protection Alliance executive director Ross Marchand says FDA needs to change its risk-averse approach to drug evaluatio...

CGMP Issues Seen in Winder Laboratories Inspection

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FDA warns Winder, GA-based Winder Laboratories about repeat CGMP violations in its manufacturing of finished drugs.

Vyvgart sBLA Seeks Expanded Use

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FDA accepts for priority review an Argenx supplemental BLA seeking to expand the use of its myasthenia gravis drug Vyvgart.

FDA Quietly Retires Autism Bogus Therapies Page

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An Ars Technica post says FDA has dropped a Web page that listed some specific bogus autism treatments and therapies and warned of...

CGMP Violation at Indias Chemspec Chemicals

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FDA warns Indias Chemspec Chemicals about CGMP deviations in its manufacturing of active pharmaceutical ingredients.