FDA clears an Integrated Endoscopy 510(k) for Nuvis Single-Use Arthroscope.
FDA warns Virginia Center for Reproductive Medicine about repeat deviations from regulations governing human cells, tissues, and cellular and tissue-b...
Four stakeholders voice support for an FDA proposal to reclassify surgical staplers and staples for internal use from Class 1 to Class 2 with special ...
FDA warns Indias Stride Pharma about CGMP violations in its production of finished drugs.
An FDA Yale-Mayo CERSI heart failure study will use the Biofourmis BiovitalsHF mobile platform to determine if quality of life characteristics should ...
Federal Register notice: FDA seeks comments on an information collection extension for focus groups on drug products.
Federal Register notice: FDA asks for comments on an information collection extension for electronic drug product reporting for human drug compounding...
FDA releases a draft guidance describing how sponsors must organize content submitted electronically to the agency.