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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...

Drug Use-Related Software Guide

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Federal Register notice: FDA makes available a draft guidance entitled Regulatory Considerations for Prescription Drug Use-Related...

English Doctor Attacks FDA/CDC Covid Vaccine Data

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A retired English doctor with almost 3 million YouTube subscribers scorns CDC and FDA data supporting mass vaccination of all Amer...

Drug Use-related Software Labeling Guide

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FDA posts a draft guidance entitled Regulatory Considerations for Prescription Drug Use-Related Software.

Substantial Evidence from 1 Trial Guidance

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FDA posts a draft guidance entitled Demonstrating Substantial Evidence of Effectiveness Based on One Adequate and Well-Controlled ...

Petition Denied on Tacrolimus Bioequivalence

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FDA denies a 4/2020 Belcher Pharmaceuticals citizen petition that sought a requirement that drug makers of pre-12/2012-approved ta...