A Senate appropriations hearing criticizes FDA commissioner Marty Makary over secrecy about the agencys fiscal year 2026 budget proposal, which calls ...
A Government Accountability Office report says FDA needs to improve its understanding and regulation of organs-on-a-chip.
FDA says it will reject all data coming from biocompatibility testing labs Mid-Link Technology Testing and Sanitation & Environment Technology Institu...
FDA warns Mt. Laurel, NJ-based United Health Products about serious violations in its clinical study of the CelluSTAT absorbable hemostat.
Moderna, at FDAs urging, voluntarily withdraws a pending BLA for mRNA-1083, its flu/COVID combination vaccine candidate.
FDA warns Holliston, MA-based NeuroSync about Quality System regulation and other violations in its manufacturing of the Eye-Sync eye assessment medic...
Johnson & Johnsons Ethicon Endo-Surgery recalls its Endopath Echelon Vascular White Reload for Advanced Placement Tip surgical stapler due to increase...
FDA warns Middletown, CT-based Microspecialties about Quality System violations in its work as a contract manufacturer of several ophthalmic surgical ...
