Food and Drug Administration (FDA) Revision of USP Chapter on Gene Therapy Medicinal Products (Catapult’s regulatory round-up – October 2024)

This chapter covers the clinical applications, manufacturing processes and analytical methods of gene therapy products, which are constantly evolving. The current amendment proposals include, for example, the following points: Delete the reference to "Safety Tests-Biologicals" in "Biological Reactivity Tests, in vivo" from the chapter Delete the Safety Tests-Biologicals section from Chapter <88>, as the corresponding FDA Code of Federal Regulations, 21 CFR §610.11, was revoked on August 3, 2015....</88>