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FDA Corrects Rule on BLA Safety Test Requirements

09/10/2014

Federal Register Proposed rule: FDA is correcting a proposed rule entitled “Revocation of General Safety Test Regulations That Are Duplicative of Requirements in Biological License Applications,” from the 8/22 Federal Register. It proposed to amend the biologics regulations by removing the general safety test requirements for biological products. The document published with the incorrect title. On page 49727, in the third column, in the heading of the document, “Revocation of General Safety Test Regulations That Are Duplicative of Requirements in Biological License Applications,” is corrected to read “Revocation of General Safety Test Regulations That Are Duplicative of Requirements in Biologics License Applications”. To view this proposed rule, click here.

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