Four stakeholders provide requested feedback to FDA on dietary supplement innovation.
Teleflex recalls its Neonatal ConchaSmart Breathing Circuit with Dual Heated Limb and ConchaSmart Column due to complaints about cracks in the device.
FDA clears an Integrated Endoscopy 510(k) for Nuvis Single-Use Arthroscope.
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FDA releases a draft guidance describing how sponsors must organize content submitted electronically to the agency.