federal_register: 2013-25956
Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API
This data as json
| document_number | title | type | abstract | publication_date | pub_year | pub_month | html_url | pdf_url | agency_names | agency_ids | excerpts |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2013-25956 | Permanent Discontinuance or Interruption in Manufacturing of Certain Drug or Biological Products | Proposed Rule | The Food and Drug Administration (FDA or the Agency) is proposing to amend its regulations to implement certain drug shortages provisions of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA). The proposed rule would require all applicants of covered approved drugs or biological products--including certain applicants of blood or blood components for transfusion and all manufacturers of covered drugs marketed without an approved application--to notify FDA electronically of a permanent discontinuance or an interruption in manufacturing of the product that is likely to lead to a meaningful disruption in supply (or a significant disruption in supply for blood or blood components) of the product in the United States. | 2013-11-04 | 2013 | 11 | https://www.federalregister.gov/documents/2013/11/04/2013-25956/permanent-discontinuance-or-interruption-in-manufacturing-of-certain-drug-or-biological-products | https://www.govinfo.gov/content/pkg/FR-2013-11-04/pdf/2013-25956.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA or the Agency) is proposing to amend its regulations to implement certain drug shortages provisions of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Food and Drug Administration Safety... |