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Evi Labs CGMP Violations

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FDA warns Medley, FL-based Evi Labs about CGMP violations in its work as a contract drug manufacturer.

Guide on 510(k) Transfers/Sales

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FDA publishes a draft guidance entitled Transfer of a Premarket Notification (510(k)) Clearance Questions and Answers.

Pandemic Diagnostic Testing Plan Needed: GAO

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The Government Accountability Office says there are things HHS, FDA, and other units should do to help create a coordinated nation...

2 FDA Officials Part of Wrongful Termination Lawsuit

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Two former FDA officials add their names to a class-action wrongful termination lawsuit alleging the federal government knowingly ...

Sources Question FDA Internal AI: NBC

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Anonymous and named sources raise questions for NBC News about FDAs use of internal AI tools in product reviews and approvals.

NDA Filed for Kuras Ziftomenib for Rare Leukemia

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FDA accepts for priority review a Kura Oncology NDA for ziftomenib, a potential new treatment for certain adult patients with rela...

Clarity Breast Gets FDA De Novo Authorization

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FDA gives de novo authorization to Clarity Breast which uses artificial intelligence to make a five-year breast cancer risk predic...

Zeta Given Another Hat at FDA Special Counsel

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FDA deputy commissioner for strategic initiatives Lowell M. Zeta adds Special Counsel for FDA role to his duties.

Makary Pledges Mifepristone Study

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FDA commissioner Martin Makary says agency scientists will review the safety of the abortion drug mifepristone based on findings f...

Makary Struggles to Clarify New Covid Recommendations

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FDA commissioner Marty Makary appears to struggle to convey the governments Covid-19 vaccine recommendations in a contentious inte...