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www.fdanews.com/articles/176529-fda-removes-outdated-biologics-guidelines

FDA Removes Outdated Biologics Guidelines

May 9, 2016

The FDA issued a final rule last week that struck outmoded manufacturing procedures and dating processes for biologics.

The rule for standard preparations and potency limits updates guidance released in 1997, and removes two sections of the Code of Federal Regulations — 21 C.F.R. §610.20 and §610.21 — because they are outdated and do not make allowance for new technologies.

Section 610.20 — which addresses standard preparation for antibodies, antigens and blood derivatives — was removed because it restricted the source of standard preparations to CBER, even though standard preparations now can be obtained from numerous sources, FDA said.

 

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