Pharmaceutical Executive January 24, 2024
Don Tracy, Associate Editor

New FDA guidelines require manufacturers to add boxed warnings to CAR T-cell therapy products.
On January 19, 2024, the FDA issued multiple notifications to drugmakers requiring boxed warnings to be added to all chimeric antigen receptor (CAR) T-cell therapy products, citing additional cancer risks associated with the treatment. The agency states that the letters “notify manufacturers of each such licensed product to update the package insert to include available information related to the risks and to update the Medication Guide for these products to identify the possibility of the increased risk of getting cancers, including certain types of cancers of the immune system.”1
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Topics: Biotechnology, FDA, Govt Agencies, Pharma / Biotech
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