FDA Related News

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.

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.

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...

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...

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...

Medical Devices

Zoll Recalls Ventilators Over Operator Guides

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

Human Drugs

Clinical Hold Lifted on Huntingtons Drug

FDA lifts a partial clinical hold on PTC Therapeutics PTC518 for treating Huntingtons disease based on the agencys review of Phase 2 trial data (PIVOT...

Human Drugs

FDA OKs Major Yescarta, Tecartus REMS Changes

FDA approves changes to the REMS for Kites lymphoma treatments Yescarta and Tecartus.

Human Drugs

4 Observations in Dr. Reddys Inspection

FDA releases the form FDA-483 issued with four observations following an inspection at the Dr. Reddys active pharmaceutical ingredient manufacturing f...

Inspection Delay, Denial, Limit, Refusal Guidance

FDA publishes a guidance describing the behaviors the agency sees as delaying, denying, limiting, or refusing a drug or device inspection.