21 CFR Part 680 - ADDITIONAL STANDARDS FOR MISCELLANEOUS PRODUCTS
Title 21 published on 2012-04-01
The following are only the Rules published in the Federal Register after the published date of Title 21.
For a complete list of all Rules, Proposed Rules, and Notices view the Rulemaking tab.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-10649 RIN Docket No. FDA-2011-N-0080 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective June 4, 2012. 21 CFR Parts 600, 610, and 680 The Food and Drug Administration (FDA) is amending the sterility test requirements for biological products. This rule provides manufacturers of biological products greater flexibility, as appropriate, and encourages use of the most appropriate and state-of-the-art test methods for assuring the safety of biological products. FDA is taking this action as part of its ongoing efforts to comprehensively review and, as necessary, revise its regulations related to biological products.
Title 21 published on 2012-04-01
The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR 680 after this date.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-12594 RIN 0910-AG16 Docket No. FDA-2011-N-0080 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule, correction. Effective June 4, 2012. 21 CFR Parts 600, 610, and 680 The Food and Drug Administration (FDA) is correcting a final rule that appeared in the Federal Register of May 3, 2012. (77 FR 26162). The final rule provides manufacturers of biological products greater flexibility, as appropriate, and encourages use of the most appropriate and state-of-the-art test methods for assuring the safety of biological products. The rule was published with an inaccurate citation in the codified section of the rule. This notice corrects that error.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-10649 RIN Docket No. FDA-2011-N-0080 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective June 4, 2012. 21 CFR Parts 600, 610, and 680 The Food and Drug Administration (FDA) is amending the sterility test requirements for biological products. This rule provides manufacturers of biological products greater flexibility, as appropriate, and encourages use of the most appropriate and state-of-the-art test methods for assuring the safety of biological products. FDA is taking this action as part of its ongoing efforts to comprehensively review and, as necessary, revise its regulations related to biological products.