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Takeda Slapped with 4-Item FDA-483

[ Price : $8.95]

FDA issues Takeda Pharmaceutical a four-item Form FDA-483 after inspecting the firms Yamaguchi, Japan manufacturing facility and f...

Cell/Gene Therapy Guide on Common Questions

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FDA posts a draft guidance entitled Frequently Asked Questions Developing Potential Cellular and Gene Therapy Products.

Aldeyra Dry Eye NDA Accepted for Review

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FDA accepts for review an Aldeyra Therapeutics NDA for reproxalap, an investigational topical new drug candidate for treating sign...

Martinez Permanently Debarred Over Trial Data

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Federal Register notice: FDA permanently debars Ivette Maria Portela Martinez from providing services to a person that has an appr...

Hydrocortone Not Withdrawn Over Safety/Efficacy

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Federal Register notice: FDA determines that Mercks Hydrocortone (hydrocortisone sodium phosphate) injection was not withdrawn due...

GAO Report Urges Key Strategies for FDA Rare Disease Efforts

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A new Government Accountability Office report urges three key strategies for FDAs programs for advancing rare disease products.

Astellas Pharma Japan Facility Hit with FDA-483

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A 2023 FDA inspection of Astellas Pharmas Shizuoka, Japan manufacturing facility leads to a one-item Form FDA-483.

Alert on VasoView Vessel Harvesting Devices

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FDA sends an alert about safety concerns with the use of Getinge/Maquets VasoView HemoPro Endoscopic Vessel Harvesting Systems.

Information Collection on Drug User Fee Program

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Federal Register notice: FDA seeks comments on an information collection revision entitled Prescription Drug User Fee Program.

Phase 3 Eye Study Terminated After Data Review

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Eyenovia decides to terminate its Phase 3 CHAPERONE study evaluating a drug-device combination of low-dose atropine as a potential...