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Clinical Investigator Didnt Meet Requirements: FDA

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FDA warns Atlanta, GA-based Dr. Han Phan about failing to ensure that a clinical investigation followed the investigational plan.

Draft Guide on Antibacterial Bovine Drugs

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Federal Register notice: FDA makes available a draft revised guidance entitled Evaluating Target Animal Safety and Effectiveness o...

Guide on Change Control Plans for AI Devices

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Federal Register notice: FDA makes available a final guidance entitled Marketing Submission Recommendations for a Predetermined Ch...

Lillys Zepbound Shows Superiority Over Wegovy: Trial

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In a head-to-head trial, Eli Lillys weight-loss drug Zepbound (tirzepatide) shows superiority over Novo Nordisks Wegovy (semagluti...

Breakthrough Status for Dravet Therapy

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FDA awards Stoke Therapeutics a breakthrough therapy designation for zorevunersen and its use in treating Dravet syndrome.

CGMP Violations at Zhejiang Uniquality

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FDA warns Chinas YouQuan Care Products about CGMP violations in its manufacturing of finished drugs.

Roivant Scraps Sarcoidosis Drug After Failed Trial

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Roivants Kinevant Sciences unit halts the development of namilumab for treating sarcoidosis after a Phase 2 study failed to show t...

FDA 2024 Guidance Report and Best Practices

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FDA issues a report and plan on best practices for guidances, incorporating comments from a 2023 draft report and plan.

Predetermined Change Control Plan Guide

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FDA publishes a guidance with recommendations for marketing submissions for Predetermined Change Control Plans for artificial inte...

Multiple Violations at S. Koreas LCC Ltd.

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FDA warns South Koreas LCC Ltd. about CGMP violations in its manufacturing of unapproved and misbranded over-the-counter drugs.