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Quality Management Benefits Exceed Costs: FDA Paper

[ Price : $8.95]

The CDER Office of Pharmaceutical Quality publishes a white paper making the economic case for quality management practices.

Antibacterial Therapies Q&A Guidance

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FDA issues a question-and-answer guidance on the development of certain antibacterial therapies.

PTC Therapeutics Phenylketonuria Drug Approved

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FDA approves a PTC Therapeutics NDA for Sephience (sepiapterin), indicated for treating adult and pediatric patients with phenylke...

User Fee Rates Set for FY 2026

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FDA posts the user fee rates for fiscal year 2026 for prescription drugs and biologics, biosimilar, medical devices and generic dr...

Guide on Aluminum Content in Parenteral Drugs

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FDA issues a revised draft guidance entitled Small Volume Parenteral (SVP) Drug Products and Pharmacy Bulk Packages for Parenteral...

FDA Probes New Death of Boy Who Got Elevidys

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FDA investigates another death of a young boy who received Sarepta Therapeutics gene therapy Elevidys for Duchenne muscular dystro...

Roche Reports Positive Data on Alzheimers Drug

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Roche announces new data on its Alzheimers therapy trontinemab and its plans to begin two Phase 3 clinical trials by the end of th...

House Reps Urge FDA Action on Counterfeit Obesity Drugs

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Bipartisan House lawmakers urge FDA to block counterfeit anti-obesity medications entering the U.S.

FDA Relents, Allows Gene Therapy Limited Use

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FDA reverses its enforcement stance against Sarepta Therapeutics and Duchenne Muscular Dystrophy gene therapy Elevidys after deter...

FDA Clears Stereotaxis MAGiC Sweep Catheter

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FDA clears a Stereotaxis 510(k) for its MAGiC Sweep catheter, a robotically navigated high-density electrophysiology mapping cathe...