Revocation of General Safety Test Regulations That Are Duplicative of Requirements in Biologics License Applications
other · Food and Drug Administration · Rule · Published 2015-07-02 · Effective 2015-08-03 · 80 FR 37971
Document
Document number
2015-16366
Federal Register citation
80 FR 37971
CFR reference
21 CFR 601
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2015-07-02
Effective date
2015-08-03
HHS docket
Docket No. FDA-2014-N-1110
Abstract
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.