PhRMA lists seven areas for which it seeks further clarification in an FDA draft guidance on combination product premarket pathway principles.
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.
FDA issues a draft guidance to help sponsors and applicants document submission of INDs, NDAs, and BLAs that contain real-world evidence.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 ...
FDA publishes two draft guidances to help give medication information to pregnant and lactating women so they may make informed decisions about their ...