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.
Reference:
FDA
(2015) Revocation of General Safety Test Regulations That Are Duplicative of Requirements
in Biologics License Applications, Federal
Register, Vol. 80, No. 127, p37971Posted by Tim Sandle
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