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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...

Ways for FDA to Modernize Biotech Regulation

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The National Security Commission on Emerging Biotechnology recommends 22 policy actions in five key areas to modernize FDA medical...

PharmaEssentia Besremi sBLA for Essential Thrombocythemia.

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FDA accepts for review a PharmaEssentia supplemental BLA seeking to expand the label of its interferon therapy Besremi to include ...

Pazdur Warns About Political Interference, Upheaval At FDA

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Former FDA Oncology Center for Excellence director Richard Pazdur warns that political interference and internal upheaval are erod...

FDA Extends Review for Filspari in Kidney Disease

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FDA extends by three months its review of a Travere Therapeutics supplemental NDA for Filspari in focal segmental glomeruloscleros...

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.

BIMO Inspection Violation in India Hospital

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FDA warns Purushothaman Kumaran about failing to follow the investigational plan for a bioequivalence study at a hospital in Pondi...