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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and clinical outcomes assessments, to the FDA will have to undergo a new qualification process, according to a draft guidance the agency issued Friday.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
The FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee voted unanimously on Friday to support Horizon Pharma’s teprotumumab infusion to treat active thyroid eye disease (TED). 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A new FDA draft guidance for sponsors developing cancer drugs would require NDAs and BLAs submitted after Aug. 18, 2020, that present a new active ingredient to include reports of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
The Senate confirmed Stephen Hahn yesterday in a 72-18 vote as the 24th FDA commissioner, taking over for acting FDA Commissioner Brett Giroir. Read More