BRIEFING

 〈1047〉 Gene Therapy Products. This proposal is based on the version of the chapter official as of November 1, 2020. It is proposed to remove the reference to Safety Tests—Biologicals in Biological Reactivity Tests, In Vivo 〈88〉 from the chapter. The section Safety Tests—Biologicals has been proposed to be deleted from 〈88〉, as the relevant FDA Code of Federal Regulations, 21 CFR §610.11, was revoked on August 3, 2015.

 Additionally, minor editorial changes have been made to update the chapter to current USP style.

 (BIO5: R. Potts)

 Case ID—SUB-505