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Army Scientific Groups Hemorrhage AI Detector Cleared

[ Price : $8.95]

FDA clears a U.S. Army Biotechnology High Performance Computing Software Applications Institute 510(k) for an artificial intellige...

Lisata Orphan Status for Osteosarcoma Drug

[ Price : $8.95]

FDA grants Lisata Therapeutics an orphan drug designation for LSTA1 and its use in treating osteosarcoma.

Italfarmaco Awarded Priority Review Voucher

[ Price : $8.95]

Federal Register notice: FDA issues a priority review voucher to Italfarmaco SpA for being the sponsor of a rare pediatric disease...

Par Sues FDA Over BPI Epinephrine Approval

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Par Pharmaceutical asks a court to stop FDA from granting final approval to a BPI epinephrine product that cites a Par product as ...

ODAC to Discuss Minimal Residual Disease Endpoint

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FDA asks the Oncologic Drugs Advisory Committee to consider whether minimal residual disease is an appropriate intermediate clinic...

Include Pregnant, Lactating Women in Trials: Report

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A new National Academies report calls on FDA and other federal government entities to take steps to increase the participation of ...

Import Alert Against China Syringe Maker

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In the latest move by FDA in its ongoing investigation into the quality of syringes made in China, the agency issues an import ale...

FDA Complex Innovative Designs Meeting Praised

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Two stakeholders comment positively on an FDA public meeting on advancing the use of complex innovative designs in clinical trials...

Multiple Violations at Kilitch Healthcare India

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FDA warns Mumbai, India-based Kilitch Healthcare India about CGMP violations in its production of sterile ophthalmic drug products...

CGMP Violations in Jiangsu Meifan Records Review

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FDA warns Jiangsu, China-based Jiangsu Meifan Biotechnology Co. about CGMP violations in the production of finished OTC drugs foun...