Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products

Docket ID: FDA-2013-N-0500
Agency: Food and Drug Administration (FDA)
Parent Agency: Department of Health and Human Services (HHS)

This rule would amend the regulations regarding new drug applications (NDAs), abbreviated new drug applications (ANDAs)., and biologics license application (BLAs) to revise and clarify procedures for changes to the labeling of an approved drug to reflect certain types of newly acquired information in advance of FDA's review of such change.

RIN: 0910-AG94
Impacts and Effects: None
CFR Citation: 21 CFR 314.70,21 CFR 314.97,21 CFR 314.150,21 CFR 601.12
Priority: Other Significant
UA and Regulatory Plan Information open glossary dialog  
Publication Period: Spring 2016
Agenda Stage of Rulemaking: Final Rule
Major Rule: No
Legal Authorities: 21 U.S.C. 321, 21 U.S.C. 331, 21 U.S.C. 352, 21 U.S.C. 353, 21 U.S.C. 355, 21 U.S.C. 371, 42 U.S.C. 262, ...
Legal Deadlines: None
Government Levels Affected: Undetermined
Federalism Implications: No
Unfunded Mandates: No
Requires Regulatory Flexibility Analysis: Business
Small Entities Affected: No
International Impacts: No
Included in Regulatory Plan: No
ActionDateFR Citation
NPRM11/13/201378 FR 67985
NPRM Comment Period Extended12/27/201378 FR 78796
NPRM Comment Period End01/13/2014
NPRM Comment Period Extended End03/13/2014
NPRM Comment Period Reopened02/18/201580 FR 8577
NPRM Comment Period Reopened End04/27/2015
Final Rule04/00/2017
Docket Details open glossary dialog  
Related RINs: None
Related Dockets: None
Short Title: Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products
Keyword(s): cder, cder20134, labeling changes, biological products, supplemetal applications, 0910-AG94
Type: Rulemaking
Docket Status: Open
Center: CDER
Docket Item Code: N

Primary Documents

View All  (17)
Comment Period Closed
Apr 27, 2015 11:59 PM ET
Proposed Rule
Posted: 02/18/2015
ID: FDA-2013-N-0500-0081
Comment Period Closed
Mar 13, 2014 11:59 PM ET
Proposed Rule
Posted: 12/27/2013
ID: FDA-2013-N-0500-0006
Comment Period Closed
Jan 13, 2014 11:59 PM ET
Proposed Rule
Posted: 11/13/2013
ID: FDA-2013-N-0500-0001
Comment Period Closed
Posted: 04/29/2015
ID: FDA-2013-N-0500-0136

Supporting Documents

View All  (20)
Comments Not Accepted
Supporting & Related Material
Posted: 04/26/2016
ID: FDA-2013-N-0500-0139
Comments Not Accepted
Supporting & Related Material
Posted: 04/03/2015
ID: FDA-2013-N-0500-0105
Comments Not Accepted
Supporting & Related Material
Posted: 02/18/2015
ID: FDA-2013-N-0500-0082


View All  (116)

Comments Received*
Regulatory Timeline
Pre Rule
Current Stage
Proposed Rule
Current Stage
Final Rule
Current Stage
Agency Contact
Janice L. Weiner
Senior Regulatory Counsel
301 796-3601
301 847-8440 (Fax)
Center for Drug Evaluation and Research, Building 51, Room 6268, 10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
*This count refers to the total comment/submissions received on this docket, as of 11:59 PM yesterday. Note: Agencies review all submissions, however some agencies may choose to redact, or withhold, certain submissions (or portions thereof) such as those containing private or proprietary information, inappropriate language, or duplicate/near duplicate examples of a mass-mail campaign. This can result in discrepancies between this count and those displayed when conducting searches on the Public Submission document type. For specific information about an agency’s public submission policy, refer to its website or the Federal Register document.