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New FDA Rare Disease Grants, Contracts

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FDA awards 19 grants and two contracts to support new medical products to treat rare diseases.

CDRH Proposes 18 FY 2023 Guidances

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CDRH publishes its A- and B-List proposed guidances to be published in FY 2023 with a retrospective list of guidances published in...

Too Few Older Adults in Trials: Study

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FDA and academic researchers say the representation of older adults in clinical trials should be improved.

Changes Urged in ANDA Amendments Appendix

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Three stakeholders suggest specific changes to Appendix A of the ANDA Amendments guidance as called for in the GDUFA 3 negotiation...

Califf Still Seeking Revamp of Accelerated Approval

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FDA commissioner Robert Califf tells the 2022 National Organization for Rare Disorders Breakthrough Summit that improvements in th...

Breast Density Notification Rule Due Soon: DeLauro

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Rep. Rosa DeLauro says FDA has told her a mandated new rule on breast density notification should be issued by early 2023.

Multiple Violations at Beijing Xinggu Lvsan

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FDA warns Chinas Beijing Xinggu Lvsan about CGMP violations in its illegal marketing of misbranded unapproved new drugs.

Draft Guide on Tissue Agnostic Drug Development

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FDA posts a draft guidance entitled Tissue Agnostic Drug Development in Oncology. The document provides recommendations to sponsor...

Settino Permanently Debarred by FDA

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Federal Register notice: FDA issues an order permanently debarring Gregory Settino from providing services related to an approved ...

Guide on Immune-mediated Adverse Reactions

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FDA posts a draft guidance entitled Characterizing, Collecting, and Reporting Immune-Mediated Adverse Reactions in Cancer Immunoth...