Rachel Park

Rachel Park

Morrison & Foerster LLP

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FDA Publishes Digital Health Technology Framework

On Thursday, March 23, 2023, the Food and Drug Administration (FDA) announced the publication of the “Framework for the Use of Digital Health Technologies in Drug and Biological Product Development” (Framework) by the Center...more

3/29/2023  /  Center for Biologics Evaluation and Research (CBER) , Center for Drug Evaluation and Research (CDER) , Digital Health , Food and Drug Administration (FDA) , Information Technology , Life Sciences , PDUFA , Prescription Drugs , Research and Development , Technology

FDA Issues Draft Guidance On Human Gene Therapy Products Incorporating Human Genome Editing

On March 14, 2022, U.S. Food and Drug Administration (FDA) issued two draft guidances: “Human Gene Therapy Products Incorporating Human Genome Editing (GE)” and a draft guidance on Chimeric Antigen Receptor (CAR) T cell...more

4/7/2022  /  Center for Biologics Evaluation and Research (CBER) , Draft Guidance , Food and Drug Administration (FDA) , Human Genes , Human Genome Project , Investigational New Drug Application (IND) , Life Sciences
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