21 CFR 680 - ADDITIONAL STANDARDS FOR MISCELLANEOUS PRODUCTS

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Authority: 21 U.S.C. 321, 351, 352, 353, 355, 360, 371; 42 U.S.C. 216, 262, 263, 263a, 264.

Source: 38 FR 32100, Nov. 20, 1973, unless otherwise noted.

Title 21 published on 2011-04-01

no entries appear in the Federal Register after this date.

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR 680

2011-06-21; vol. 76 # 119 - Tuesday, June 21, 2011

76 FR 36019 - Amendments to Sterility Test Requirements for Biological Products

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Additional Documents

type	regulations.gov
FR Doc.	2011-15346
RIN
Docket No.	FDA-2011-N-0080

DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration

Proposed rule.

Submit either electronic or written comments on this proposed rule by September 19, 2011. See section X of this document for the proposed effective date of any final rule that may publish based on this proposal.

21 CFR Parts 600, 610, and 680

Summary

The Food and Drug Administration (FDA) proposes to amend the sterility test requirements for biological products. This proposed rule is intended to provide manufacturers of biological products greater flexibility and to encourage use of the most appropriate and state-of-the-art test methods for assuring the safety of biological products. We are taking this action as part of our continuing effort to review and, as necessary, update the biologics regulations.

21 CFR 680 - ADDITIONAL STANDARDS FOR MISCELLANEOUS PRODUCTS

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