Anonymous and named sources raise questions for NBC News about FDAs use of internal AI tools in product reviews and approvals.
FDA commissioner Martin Makary says agency scientists will review the safety of the abortion drug mifepristone based on findings from a study conducte...
FDA commissioner Marty Makary appears to struggle to convey the governments Covid-19 vaccine recommendations in a contentious interview on CBSs Face t...
FDA warns Swedens Rechon Life Sciences about CGMP violations in its production of finished drugs.
FDA warns Chinas Zhejiang Easyclean Daily Chemical Co. about CGMP violations in its production of finished drugs.
Two Hyman, Phelps & McNamara attorneys say FDA may give research-use-only products greater regulatory scrutiny as a way to maintain some level of cont...
CBER director Vinay Prasad outlines his expectations for advancing rare disease products, such as embracing both surrogate endpoints for accelerated a...
FDA approves a Bayer Healthcare Pharmaceuticals supplemental NDA for Nubega (darolutamide) for metastatic castration-sensitive prostate cancer.
