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Hold Lifted on INmune Alzheimers Trial

[ Price : $8.95]

FDA lifts a 2022-imposed clinical hold against INmune Bios XPro (XPro1595; pegipanermin) and its Alzheimers disease clinical trial...

Feds Looking at Medical Record AI: Bloomberg

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Bloomberg Law says the Justice Department is looking into the use of AI in electronic health records to push doctors to prescribe ...

Enhertu sBLA Priority Review for Solid Tumors

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FDA accepts for priority review an AstraZeneca and Daiichi Sankyo supplemental BLA for Enhertu (trastuzumab deruxtecan) for treati...

Ban Skin Shock Devices: 29 Associations

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Some 29 advocacy groups call on FDA to act quickly to finalize a ban on electric skin shock devices used to treat self-injurious o...

CGMP Violations at Thailands S&J International

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FDA warns Thailands S&J International Enterprises about CGMP violations in its production of finished drugs and refusing to allow ...

Court Orders FDA Hetlioz Action

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The DC federal court orders FDA to act on a Vanda sNDA for a Hetlioz indication to treat jet lag disorder or schedule a hearing on...

CAR T-Cell Development Considerations Guide

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FDA posts a guidance entitled Considerations for the Development of Chimeric Antigen Receptor T Cell Products.

Guide on Race/Ethnicity Data Reporting

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FDA releases a draft guidance entitled Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regul...

Remote Regulatory Assessments Q&A Guide

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Federal Register notice: FDA makes available a revised draft guidance entitled Conducting Remote Regulatory Assessments Question ...

Safety Surveillance Best Practices Document

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Federal Register notice: FDA makes available a final document entitled Best Practices for FDA Staff in the Postmarketing Safety Su...