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Require Prednisolone Solution Studies: DifGen

[ Price : $8.95]

DifGen asks FDA to require stability studies under refrigerated conditions for all ANDAs for prednisolone ophthalmic solution 1%.

Clinical Investigator Didnt Meet Requirements: FDA

[ Price : $8.95]

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.

Review Voucher Issued to PTC Therapeutics

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Federal Register notice: FDA issues a priority review voucher to PTC Therapeutics for its qualified rare pediatric disease product...

Comments Extended on Smoking Cessation Products

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Federal Register notice: FDA reopens the comment period associated with a 10/21 public meeting on Advancing Smoking Cessation: Foo...

Cytokinetics NDA Filed for Hypertrophic Cardiomyopathy

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FDA accepts for review a Cytokinetics NDA for aficamten, a cardiac myosin inhibitor for treating obstructive hypertrophic cardiomy...

CGMP Violations at Zhejiang Uniquality

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