We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
PhRMA is suing the state of Oregon in federal court to block enforcement of two drug price transparency laws — including one set to go into effect on January 1. Read More
Sponsors voluntarily submitting drug development tools (DDT), such as biomarkers and clinical outcomes assessments, to the FDA will have to undergo a new qualification process, according to a draft guidance the agency issued Friday. Read More
A new FDA draft guidance for sponsors developing cancer drugs would require NDAs and BLAs submitted after Aug. 18, 2020, that present a new active ingredient to include reports of molecularly targeted pediatric cancer investigations unless a deferral or waiver is granted by the FDA. Read More