Title 21 published on 2014-04-01
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.
2014-09-08; vol. 79 # 173 - Monday, September 8, 2014 79 FR 53133 - Postmarketing Safety Reports for Human Drug and Biological Products; Electronic Submission Requirements; Correction
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule; correction. Effective date: September 8, 2014. 21 CFR Parts 310, 314, 329, and 600 Summary The Food and Drug Administration (FDA) is correcting a final rule entitled “Postmarketing Safety Reports for Human Drug and Biological Products; Electronic Submission Requirements” that appeared in the Federal Register of June 10, 2014 (79 FR 33072). The document amended FDA's postmarketing safety reporting regulations for human drug and biological products to require that persons subject to mandatory reporting requirements submit safety reports in an electronic format that FDA can process, review, and archive. The document was published with an incorrect RIN number. This document corrects the error.
79 FR 53133 - Postmarketing Safety Reports for Human Drug and Biological Products; Electronic Submission Requirements; Corrections
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule; corrections. Effective Date: September 8, 2014. 21 CFR Part 310, 314, 329, and 600 Summary The Food and Drug Administration (FDA) is correcting a document entitled “Postmarketing Safety Reports for Human Drug and Biological Products; Electronic Submission Requirements; Correction” that appeared in the Federal Register of August 14, 2014 (79 FR 47655). The document published without the required RIN number and in the Notice category. This document corrects those errors.
2014-06-10; vol. 79 # 111 - Tuesday, June 10, 2014 79 FR 33072 - Postmarketing Safety Reports for Human Drug and Biological Products; Electronic Submission Requirements
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective June 10, 2015. 21 CFR Parts 310, 314, 329, and 600 Summary The Food and Drug Administration (FDA or we) is amending its postmarketing safety reporting regulations for human drug and biological products to require that persons subject to mandatory reporting requirements submit safety reports in an electronic format that FDA can process, review, and archive. FDA is taking this action to improve the Agency's systems for collecting and analyzing postmarketing safety reports. The change will help the Agency to more rapidly review postmarketing safety reports, identify emerging safety problems, and disseminate safety information in support of FDA's public health mission. In addition, the amendments will be a key element in harmonizing FDA's postmarketing safety reporting regulations with international standards for the electronic submission of safety information.
This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.
This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office] .
It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.
United States Code U.S. Code: Title 21 - FOOD AND DRUGS U.S. Code: Title 42 - THE PUBLIC HEALTH AND WELFARE
Title 21 published on 2014-04-01
The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR 600 after this date.
2014-09-08; vol. 79 # 173 - Monday, September 8, 2014 79 FR 53133 - Postmarketing Safety Reports for Human Drug and Biological Products; Electronic Submission Requirements; Correction
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule; correction. Effective date: September 8, 2014. 21 CFR Parts 310, 314, 329, and 600 Summary The Food and Drug Administration (FDA) is correcting a final rule entitled “Postmarketing Safety Reports for Human Drug and Biological Products; Electronic Submission Requirements” that appeared in the Federal Register of June 10, 2014 (79 FR 33072). The document amended FDA's postmarketing safety reporting regulations for human drug and biological products to require that persons subject to mandatory reporting requirements submit safety reports in an electronic format that FDA can process, review, and archive. The document was published with an incorrect RIN number. This document corrects the error.
79 FR 53133 - Postmarketing Safety Reports for Human Drug and Biological Products; Electronic Submission Requirements; Corrections
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule; corrections. Effective Date: September 8, 2014. 21 CFR Part 310, 314, 329, and 600 Summary The Food and Drug Administration (FDA) is correcting a document entitled “Postmarketing Safety Reports for Human Drug and Biological Products; Electronic Submission Requirements; Correction” that appeared in the Federal Register of August 14, 2014 (79 FR 47655). The document published without the required RIN number and in the Notice category. This document corrects those errors.
2014-06-10; vol. 79 # 111 - Tuesday, June 10, 2014 79 FR 33072 - Postmarketing Safety Reports for Human Drug and Biological Products; Electronic Submission Requirements
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective June 10, 2015. 21 CFR Parts 310, 314, 329, and 600 Summary The Food and Drug Administration (FDA or we) is amending its postmarketing safety reporting regulations for human drug and biological products to require that persons subject to mandatory reporting requirements submit safety reports in an electronic format that FDA can process, review, and archive. FDA is taking this action to improve the Agency's systems for collecting and analyzing postmarketing safety reports. The change will help the Agency to more rapidly review postmarketing safety reports, identify emerging safety problems, and disseminate safety information in support of FDA's public health mission. In addition, the amendments will be a key element in harmonizing FDA's postmarketing safety reporting regulations with international standards for the electronic submission of safety information.
