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FDA awards 19 grants and two contracts to support new medical products to treat rare diseases.[ Price : $8.95]
CDRH publishes its A- and B-List proposed guidances to be published in FY 2023 with a retrospective list of guidances published in...[ Price : $8.95]
FDA and academic researchers say the representation of older adults in clinical trials should be improved.[ Price : $8.95]
Three stakeholders suggest specific changes to Appendix A of the ANDA Amendments guidance as called for in the GDUFA 3 negotiation...[ Price : $8.95]
FDA commissioner Robert Califf tells the 2022 National Organization for Rare Disorders Breakthrough Summit that improvements in th...[ Price : $8.95]
Rep. Rosa DeLauro says FDA has told her a mandated new rule on breast density notification should be issued by early 2023.[ Price : $8.95]
FDA warns Chinas Beijing Xinggu Lvsan about CGMP violations in its illegal marketing of misbranded unapproved new drugs.[ Price : $8.95]
FDA posts a draft guidance entitled Tissue Agnostic Drug Development in Oncology. The document provides recommendations to sponsor...