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Human Genes Center for Biologics Evaluation and Research (CBER)

MoFo Life Sciences

FDA Issues Draft Guidance On Human Gene Therapy Products Incorporating Human Genome Editing

MoFo Life Sciences on

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(FDA) issued two draft guidances: “Human Gene Therapy Products Incorporating Human Genome Editing (GE)” and a draft guidance on Chimeric Antigen Receptor (CAR) T cell...more

King & Spalding

The End of Enforcement Discretion for Cell & Gene Therapies: Thinking Through Next Steps

King & Spalding on

Beginning this week, the U.S. Food and Drug Administration (“FDA”) ended its compliance and enforcement discretion policy with regard to certain human cell, tissue, and cellular and tissue-based products (“HCT/Ps”). HCT/P...more

Womble Bond Dickinson

Cancer Vaccines: The Fourth Pillar of Anti-Cancer Therapy?

Womble Bond Dickinson on

Innovative technologies are being deployed to address the Western world’s major killer: cancer. Traditionally, cancer treatment has included surgery, chemotherapy, and radiation, but recently, the development of targeted...more

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