The International Council for Harmonization releases for public comments a revised draft guideline entitled General Considerations For Clinical Studie...
Bristol-Myers Squibb says its Phase 3 CheckMate-498 trial evaluating Opdivo (nivolumab) versus temozolomide did not meet its primary endpoint of overa...
FDA issues a guidance to help oncology drug sponsors evaluate reproductive toxicity effects of their drugs.
Federal Register notice: FDA makes available a final guidance entitled Utilizing Animal Studies to Evaluate Organ Preservation Devices.
Federal Register notice: FDA sends to OMB an information collection extension entitled Electronic Submission of Medical Device Registration and Listin...
FDA issues a draft guidance to help sponsors and applicants document submission of INDs, NDAs, and BLAs that contain real-world evidence.
Federal Register notice: FDA submits to OMB a new information collection entitled Experimental Study of an Accelerated Approval Disclosure.
Federal Register notice: FDA sends to OMB a new information collection entitled Clinical Use of Bulk Drug Substances Nominated for Use in Compounding ...