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Latest From Sue Sutter
Janssen and Amgen suggest user fee agreement changes aimed at speeding review process for some biosimilar applications and supplements in comments to US FDA on biologic product competition and innovation, while Merck presses agency to clarify its current view on cross-product labeling.
Cardiovascular and non-CV safety findings from completed outcomes trials to date for eight drugs, as well as the relative paucity of preapproval CV data available for anti-diabetic agents prior to a December 2008 guidance that mandated dedicated risk assessments, may inform advisory committee's view on continuing need for large safety trials.
Keeping Track: Pfizer’s Talzenna Ensures Record Year For Novel US Approvals; Novartis Submits SMA Gene Therapy
The latest drug development news and highlights from our FDA Performance Tracker.
Centers for Medicare and Medicaid Services asks whether private actions under Lanham Act are sufficient for enforcement, or whether participation in federal health programs should be conditioned on including drug list prices in direct-to-consumer TV commercials; comment deadline on controversial proposed rule is Dec. 17.
In unanimously endorsing prucalopride for chronic idiopathic constipation, advisory committee seems reassured by extensive data on 5-HT4 agonist’s cardiovascular safety, but some members called for an epidemiological study to assess possible suicidality signal.
Voluntary precertification process could help ensure the quality and integrity of databases from which real-world evidence is derived, but the program could be a cost burden for data curators and accreditation criteria would need to be developed, experts said at a recent Duke-Margolis Center meeting.