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CDER Publishes AI/ML Discussion Paper

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CDER director Patrizia Cavazzoni says the Center is working with CBER and CDRH on discussion papers involving artificial intellige...

Reviewers Question Sarepta DMD Drug

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FDA medical reviewers question the effectiveness and safety of Sareptas SRP-9001 as a treatment for some cases of Duchenne muscula...

Bill Would Force Drug Research Cost Disclosure

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Three congressional Democrats introduce legislation to require drug companies to accurately account for how much they spend on dru...

FDA Clears Renuvion Handpiece

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FDA clears the Apyx Renuvion/J-Plasma handpiece for coagulation of subcutaneous soft tissues following liposuction for aesthetic b...

Enzyme Replacement Therapy OKd for Fabry Disease

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FDA approves a Chiesi Global Rare Diseases and Protalix BioTherapeutics BLA for Elfabrio (pegunigalsidase alfa-iwxj) for treating ...

Panel Unanimously Backs OTC Contraceptive Pill

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An FDA advisory committee recommends the approval of a Laboratoire HRA Pharma NDA seeking a prescription-to-nonprescription switch...

FDA Clears Hubly Drill for Brain Burr Holes

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FDA clears a Hubly Surgical 510(k) for the Hubly Drill and its use in performing burr hole procedures as part of brain surgery.

FDA, NIST Animal Product Resource Development

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FDA announces a joint project with the National Institute of Standards and Technology to develop resources needed by animal biotec...

Regulatory Review for Somscans Detectnet

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Federal Register notice: FDA determines for patent term extension purposes the regulatory review period for Somscans Detectnet (c...

Glycol Testing Guidance

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FDA publishes an immediately-effective guidance to help drug manufacturers, repackers, and compounders prevent the use of glycol-c...