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Human Drugs

Committee Finds Troubling Foreign Inspection Issues

The House Energy and Commerce Committee seeks additional inspection records from FDA after its analysis of the foreign drug inspection program found t...

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Human Drugs

FDA Denies Petition Seeking Wakix Withdrawal

FDA denies a 4/2023 petition that called on the agency to withdraw approval for Harmony Biosciences Wakix (pitolisant) and take other actions against ...

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Human Drugs

Lexicon Refiles NDA for Sotagliflozin

After receiving a 2019 complete response letter, Lexicon Pharmaceuticals resubmits its NDA for sotagliflozin oral tablets as an adjunct to insulin the...

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Biologics

Dj vu: Marks Overrides Reviewers on Duchenne Drug Again

CBER director Peter Marks again overrides his Centers review teams in approving a supplemental BLA that expands the approval and converts to full appr...

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Medical Devices

Zoll Recalls Ventilators Over Operator Guides

Zoll Medical recalls (Class 1) its Zoll 731 Ventilators and their operator and quick reference guides.

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Federal Register

Switching Studies for Interchangeable Biosimilars Guide

Federal Register notice: FDA makes available a draft guidance entitled Considerations in Demonstrating Interchangeability With a Reference Product: Up...

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Federal Register

Guide on Adulteration when Inspection Refused

Federal Register notice: FDA makes available a final guidance entitled Circumstances That Constitute Delaying, Denying, Limiting, or Refusing a Drug o...

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Federal Register

Guide on Human User Safety in Animal Drugs

Federal Register notice: FDA makes available a final guidance entitled Human User Safety in New and Abbreviated New Animal Drug Applications.

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Human Drugs

Workshop on NDA/BLA Meeting Management Practices

FDA announces a 7/22 public workshop on Best Practices for Meeting Management Under PDUFA VII.

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Human Drugs

Lillys Files Mounjara NDA for Sleep Apnea

Eli Lilly says it has submitted an NDA for weight loss therapy Mounjaro (tirzepatide) for treating moderate-to-severe obstructive sleep apnea and obes...