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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and clinical outcomes assessments, to the FDA will have to undergo a new qualification process, according to a draft guidance the agency issued Friday.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A new FDA draft guidance for sponsors developing cancer drugs would require NDAs and BLAs submitted after Aug. 18, 2020, that present a new active ingredient to include reports of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
On an almost party-line vote of 230-192, the Democrats’ drug pricing bill H.R. 3 made its way out of the House on Thursday with an amendment requiring drugmakers to disclose drug prices in their direct-to-consumer advertising. Read More