Federal Register notice: FDA sends to OMB a proposed information collection entitled Annual Summary Reporting Requirements Under the Right to Try Act....
For the second time in a year, FDA inspects contract manufacturer Catalents Brussels, Belgium, manufacturing facility.
Federal Register notice: FDA extends the comment period for a 6/28 proposed rule entitled Nonprescription Drug Product With an Additional Condition fo...
Federal Register notice: FDA makes available a draft guidance entitled Select Updates for the Breakthrough Devices Program Guidance: Reducing Disparit...
Federal Register notice: FDA makes available a final guidance entitled Multiple Endpoints in Clinical Trials.
Federal Register notice: FDA extends the period before it intends to begin enforcing a statutory 5% limit on distribution of compounded human drug pro...
Federal Register notice: FDA announces the continuation of its paired meeting program that aims to advance the use of complex innovative trial designs...
FDA posts a final guidance entitled Human Gene Therapy for Neurodegenerative Diseases.
