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Par Sues FDA Over BPI Epinephrine Approval

[ Price : $8.95]

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...

Fast Track for Phanes Lung Cancer Drug

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FDA grants Phanes Therapeutics a fast track designation for PT217 and its use in treating patients with extensive-stage small cell...

No Benefit in Many Cancer Accelerated Approvals

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Harvard Medical School researchers say fewer than half of the cancer drugs given accelerated approval between 2013 and 2023 demons...

Susceptibility Test Interpretive Criteria Updates

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Federal Register notice: FDA makes available its annual compilation of update notices to the agencys Susceptibility Test Interpret...