federal_register: 2011-32354
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2011-32354 | Applications for Food and Drug Administration Approval To Market a New Drug; Revision of Postmarketing Reporting Requirements-Discontinuance | Rule | The Food and Drug Administration (FDA or the Agency) is issuing an interim final rule amending its postmarketing reporting regulations implementing certain provisions of the Federal Food, Drug and Cosmetic Act. The provisions of the Federal Food, Drug and Cosmetic Act require manufacturers who are the sole manufacturers of certain drug products to notify FDA at least 6 months before discontinuance of manufacture of the products. This interim final rule modifies the term "discontinuance" and clarifies the term "sole manufacturer" with respect to notification of discontinuance requirements. The broader reporting resulting from these changes will enable FDA to improve its collection and distribution of drug shortage information to physician and patient organizations and to work with manufacturers and other stakeholders to respond to potential drug shortages. | 2011-12-19 | 2011 | 12 | https://www.federalregister.gov/documents/2011/12/19/2011-32354/applications-for-food-and-drug-administration-approval-to-market-a-new-drug-revision-of | https://www.govinfo.gov/content/pkg/FR-2011-12-19/pdf/2011-32354.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA or the Agency) is issuing an interim final rule amending its postmarketing reporting regulations implementing certain provisions of the Federal Food, Drug and Cosmetic Act. The provisions of the Federal Food, Drug... |