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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...

Rechon Life Sciences Violations

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FDA warns Swedens Rechon Life Sciences about CGMP violations in its production of finished drugs.

CGMP Violations at Zhejiang Easyclean

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FDA warns Chinas Zhejiang Easyclean Daily Chemical Co. about CGMP violations in its production of finished drugs.

FDA Drops LDT Regulation, Looks to RUOs: Attorneys

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Two Hyman, Phelps & McNamara attorneys say FDA may give research-use-only products greater regulatory scrutiny as a way to maintai...

CBERs Prasad Outlines Rare Disease Goals

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CBER director Vinay Prasad outlines his expectations for advancing rare disease products, such as embracing both surrogate endpoin...