Friday 4 September 2015

FDA - Changes for General Safety Test

The Food and Drug Administration (FDA) is amending the biologics regulations by removing the general safety test (GST) requirements for biological products. FDA is finalizing this action because the existing codified GST regulations are duplicative of requirements that are also specified in biologics license applications (BLAs), or are no longer necessary or appropriate to help ensure the safety, purity, and potency of licensed biological products. FDA is taking this action as part of its retrospective review of its regulations to promote improvement and innovation, in response to the Executive order.

DATES: This rule is effective August 3, 2015.


FDA (2015) Revocation of General Safety Test Regulations That Are Duplicative of Requirements in Biologics License Applications, Federal Register, Vol. 80, No. 127, p37971

Posted by Tim Sandle

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