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Federal Register

Guide on Genome Editing Gene Therapies

Federal Register notice: FDA makes available a final guidance entitled Human Gene Therapy Products Incorporating Human Genome Editing.

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Federal Register

Guide on CAR T Cell Product Development

Federal Register notice: FDA makes available a final guidance entitled Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Pr...

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Federal Register

Draft Guide on Race/Ethnicity Trial Data

Federal Register notice: FDA makes available a draft guidance entitled Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies f...

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Human Drugs

Hold Lifted on INmune Alzheimers Trial

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

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Feds Looking at Medical Record AI: Bloomberg

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

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Biologics

Enhertu sBLA Priority Review for Solid Tumors

FDA accepts for priority review an AstraZeneca and Daiichi Sankyo supplemental BLA for Enhertu (trastuzumab deruxtecan) for treating adult patients wi...

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Medical Devices

Ban Skin Shock Devices: 29 Associations

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

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Human Drugs

CGMP Violations at Thailands S&J International

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

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Human Drugs

Court Orders FDA Hetlioz Action

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 the submission.

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Biologics

CAR T-Cell Development Considerations Guide

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