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FDA Science Board Renewed for 2 Years

[ Price : $8.95]

Federal Register notice: FDA announces the renewal of its Science Board for an additional two years.

CDER Wants AI Use in Drug Safety: Attorneys

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Troutman Pepper attorneys explain the potential benefits in FDAs new Emerging Drug Safety Technology Program.

Advisory Panel to Discuss Pediatric RSV Vaccine Safety

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FDA plans to ask its Vaccines and Related Biological Products Advisory Committee to discuss potential safety concerns related to p...

NIH Ends Mpox Study Early

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The National Institutes of Health ends a trial of an mpox antiviral drug that failed to produce an efficacy signal.

Carvykti Shows Favorable Minimal Residual Disease Data

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Johnson & Johnson reports data from its Phase 3 CARTITUDE-4 study that show Carvykti significantly increased minimal residual dise...

OCI Case Nets 2 on HIV, Covid Drug Convictions

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Two men are convicted of securities fraud in a case involving misrepresented submissions to FDA for a drug purportedly intended to...

CGMP Violations at Chinas Guangzhou Four Es

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FDA warns Chinas Guangzhou Four Es Scientific Co. about CGMP violations in its production of finished drugs.

Getinge/Maquet Recalls VasoView HemoPro 2

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Getinge/Maquet issues a Class 1 recall (device correction) to inform users about important safety information for its VasoView Hem...

FDA Stem Cell Regulation Court Ruling Analyzed

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Four Ropes & Gray attorneys analyze a 9th Circuit Appeals Court decision backing FDA regulation of stem cell products and raise th...