RIN Data
| HHS/FDA | RIN: 0910-AG94 | Publication ID: Spring 2013 |
| Title: ●Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products | |
| Abstract: This proposed rule would amend the regulations regarding new drug applications (NDAs), abbreviated new drug applications (ANDAs), and biologics license applications (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. The proposed rule would describe the process by which information regarding a "changes being effected" (CBE) labeling supplement submitted by an NDA or ANDA holder would be made publicly available during FDA's review of the labeling change. The proposed rule also would clarify requirements for the NDA holder for the reference listed drug and all ANDA holders to submit conforming labeling revisions after FDA has taken an action on the NDA and/or ANDA holder's CBE labeling supplement. These proposed revisions to FDA's regulations would create parity between NDA holders and ANDA holders with respect to submission of CBE labeling supplements. | |
| Agency: Department of Health and Human Services(HHS) | Priority: Other Significant |
| RIN Status: First time published in the Unified Agenda | Agenda Stage of Rulemaking: Proposed Rule Stage |
| Major: Undetermined | Unfunded Mandates: No |
| CFR Citation: 21 CFR 314.70 21 CFR 314.97 21 CFR 314.150 21 CFR 601.12 | |
| Legal Authority: 21 USC 321 21 USC 331 21 USC 352 21 USC 353 21 USC 355 21 USC 371 42 USC 262 ... | |
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Legal Deadline:
None |
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Timetable:
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| Regulatory Flexibility Analysis Required: Yes | Government Levels Affected: Undetermined |
| Small Entities Affected: Businesses | Federalism: No |
| Included in the Regulatory Plan: No | |
| International Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest. | |
| RIN Data Printed in the FR: Yes | |
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Agency Contact: Janice L. Weiner Principal Regulatory Counsel Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research, 10903 New Hampshire Avenue, Building 51, Room 6270, Silver Spring, MD 20993-0002 Phone:301 796-3475 Fax:301 847-8440 Email: janice.weiner@fda.hhs.gov |
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