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FDA General

CVMs Solomon Retiring at Year End

Center for Veterinary Medicine director Steven Solomon announces his retirement, effective at the end of the year.

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Federal Register

Guide on AML Drug Development Considerations

Federal Register notice: FDA makes available a final guidance entitled Acute Myeloid Leukemia: Developing Drugs and Biological Products for Treatment....

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Federal Register

Draft Guide on Cancer Immunotherapeutic Trials

Federal Register notice: FDA makes available a draft guidance entitled Characterizing, Collecting, and Reporting Immune-Mediated Adverse Reactions in ...

Federal Register

Oncology Guide on Tissue Agnostic Drugs

Federal Register notice: FDA makes available a draft guidance entitled Tissue Agnostic Drug Development in Oncology.

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Medical Devices

Quality System, Other Violations at Forcemech

FDA warns Pearland, TX-based Forcemech International about Quality System and other violations in its importation and distribution of powered wheelcha...

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Human Drugs

New FDA Rare Disease Grants, Contracts

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

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Medical Devices

CDRH Proposes 18 FY 2023 Guidances

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...

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Human Drugs

Too Few Older Adults in Trials: Study

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

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Human Drugs

Changes Urged in ANDA Amendments Appendix

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

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Human Drugs

Califf Still Seeking Revamp of Accelerated Approval

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