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〈1041〉 Biologics

BRIEFING

〈1041〉 Biologics. This proposal is based on the version of the chapter official as of May 1, 2018. 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has been proposed to be deleted from 〈88〉, as the relevant FDA Code of Federal Regulations, 21 CFR §610.11, was revoked on August 3, 2015. Edits have been made to the first section of the chapter to remove outdated text.

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

 (BIO2: R. Potts)

 Case ID—SUB-34

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