FDA posts a guidance outlining its intent to exempt several low-risk, unclassified medical devices from premarket notification requirements.
A Friends of Cancer Research white paper recommends three ways the FDA Biomarker Qualification Program could be improved.
U.S. House lawmakers introduce bipartisan legislation aimed at expanding federal scrutiny of U.S. investments in China's biotechnology sector, arguing...
Former FDAers Richard Pazdur and Nicole Gormley promote ways to restructure the agency so it can be more independent and successful.
FDA issues an untitled letter to QOL Medical, alleging that promotional emails for its rare-disease therapy Sucraid (sacrosidase) Oral Solution were f...
FDA sends a Warning Letter to Brazilian over-the-counter drug manufacturer Aeroflex Industria de Aerosol after the company failed to respond to multip...
FDA warns St. Paul, MN-based HealthPartners Neuroscience Center Research and Innovation about good laboratory practice violations in its conduct of no...
Two Morgan Lewis attorneys explain a new FDA draft guidance on three-year drug exclusivity for new clinical investigations.
