21 physician organizations ask FDA not to finalize a guidance on insanitary conditions in drug compounding facilities in a way that would restrict the...
Federal Register notice: FDA determines that Sunovion Pharmaceuticals Zonegran (zonisamide) was not withdrawn for safety or effectiveness reasons.
President Donald Trump orders the Veterans Administration to obtain supplies of Johnson & Johnsons Spravato for use with suicidal veterans.
The HHS Inspection General says FDA is making progress in submitting clearance documents for FY 2015 and 2016 audit recommendations.
Former FDA commissioner Jane Henney and Chicago Community Fund CEO Helene Gayle urge FDA to reevaluate the distribution restrictions currently in plac...
Regeneron asks FDA to clarify a draft guidance on developing endpoints for testing drugs intended to treat heart failure.
The Avoca Group explains the elements involved in taking a risk-based approach to clinical trial inspection readiness.
FDA issues an updated Clinical Outcome Assessment Compendium for use in determining how clinical outcome assessments may be used in clinical trials.