CDRH publishes its A- and B-List proposed guidances to be published in FY 2023 with a retrospective list of guidances published in 1983, 1993, 2003, a...
FDA and academic researchers say the representation of older adults in clinical trials should be improved.
Three stakeholders suggest specific changes to Appendix A of the ANDA Amendments guidance as called for in the GDUFA 3 negotiations.
FDA commissioner Robert Califf tells the 2022 National Organization for Rare Disorders Breakthrough Summit that improvements in the accelerated drug a...
Rep. Rosa DeLauro says FDA has told her a mandated new rule on breast density notification should be issued by early 2023.
FDA warns Chinas Beijing Xinggu Lvsan about CGMP violations in its illegal marketing of misbranded unapproved new drugs.
FDA posts a draft guidance entitled Tissue Agnostic Drug Development in Oncology. The document provides recommendations to sponsors on considerations ...
Federal Register notice: FDA issues an order permanently debarring Gregory Settino from providing services related to an approved or pending drug prod...
