BIO Submits Comments on Proposed Rule Revocation of Duplicative Requirements in BLAs
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The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the proposed rule “Revocation of General Safety Test Regulations That Are Duplicative of Requirements in Biological License Applications.”</p>
BIO’s comments commend the FDA on retrospectively reviewing its regulations to promote improvement and innovation. In particular, BIO fully supports FDA’s decision to amend the biologics regulations by removing the general safety test requirements for biological products, as it is a positive step both in eliminating the use of an assay that is no longer needed to ensure the safety of products based on more advanced testing that is now being conducted and also, importantly, reduces the use of animals.
