federal_register: 2013-30881
Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API
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| document_number | title | type | abstract | publication_date | pub_year | pub_month | html_url | pdf_url | agency_names | agency_ids | excerpts |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2013-30881 | Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products; Correction and Extension of Comment Period | Proposed Rule | The Food and Drug Administration (FDA) is correcting, and extending the comment period for, the proposed rule that appeared in the Federal Register of November 13, 2013. In the proposed rule, FDA requested comments on the proposal to revise and clarify procedures for application holders of an approved drug or biological product to change the product labeling to reflect certain types of newly acquired information in advance of FDA's review of the change. The proposed rule published without a reference or a link to the accompanying Regulatory Impact Analysis. The Agency is taking this action to correct this omission and to extend the comment period in response to requests for an extension to allow interested persons additional time to submit comments on the proposed rule. | 2013-12-27 | 2013 | 12 | https://www.federalregister.gov/documents/2013/12/27/2013-30881/supplemental-applications-proposing-labeling-changes-for-approved-drugs-and-biological-products | https://www.govinfo.gov/content/pkg/FR-2013-12-27/pdf/2013-30881.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA) is correcting, and extending the comment period for, the proposed rule that appeared in the Federal Register of November 13, 2013. In the proposed rule, FDA requested comments on the proposal to revise and clarify... |