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FDA Converts ASCA from Pilot to Permanent

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FDA says it is converting its medical device Accreditation Scheme for Conformity Assessment from a pilot to a permanent program.

Houston Man Sentenced in Counterfeit Drugs Case

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A federal judge sentences Byron A. Marshall of Houston, TX to 300 months in federal prison for his role in leading a counterfeit d...

Guide on Drug Substantial Evidence

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Federal Register notice: FDA makes available a draft guidance entitled Demonstrating Substantial Evidence of Effectiveness Based o...

E-signature, E-records Info Collection

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Federal Register notice: FDA seeks comments on an information collection revision entitled Electronic Records; Electronic Signatur...

Info Collection on Fellowship Program

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Federal Register notice: FDA seeks comments on an information collection extension entitled Application for Participation in FDA F...

Vanda Hetlioz Dispute with FDA Heats Up

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Vanda Pharmaceuticals calls on FDA commissioner Robert Califf to throw out a second CDER proposed order on the companys sNDA for a...

Atara Bio Plans BLA for Tabelecleucel

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Atara Biotherapeutics says it expects to file by 7/2024 a BLA for tabelecleucel, an allogeneic, Epstein-Barr virus-specific T-cell...

CGMP, Other Violations at PureChemPros

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FDA warns Tempe, AZ-based PureChemPros it is illegally manufacturing and distributing unapproved and misbranded new drugs that vio...

FDA Information Technology Plan

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Federal Register notice: FDA releases its FDA Information Technology Strategy, which is open for comments until 10/30.

Breakthrough for Parkinsons Neurostimulator

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FDA grants InBrain Neuroelectronics a breakthrough device designation for its Intelligent Network Modulation System and its use as...