federal_register: 2015-16367
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2015-16367 | Removal of Review and Reclassification Procedures for Biological Products Licensed Prior to July 1, 1972 | Proposed Rule | The Food and Drug Administration (FDA) proposes to remove two regulations that prescribe procedures for FDA's review and classification of biological products licensed before July 1, 1972. FDA is taking this action because the two regulations are obsolete and no longer necessary in light of other statutory and regulatory authorities established since 1972, which allow FDA to evaluate and monitor the safety and effectiveness of all biological products. In addition, other statutory and regulatory authorities authorize FDA to revoke a license for products because they are not safe and effective, or are misbranded. FDA is taking this action as part of its retrospective review of its regulations to promote improvement and innovation. | 2015-07-02 | 2015 | 7 | https://www.federalregister.gov/documents/2015/07/02/2015-16367/removal-of-review-and-reclassification-procedures-for-biological-products-licensed-prior-to-july-1 | https://www.govinfo.gov/content/pkg/FR-2015-07-02/pdf/2015-16367.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA) proposes to remove two regulations that prescribe procedures for FDA's review and classification of biological products licensed before July 1, 1972. FDA is taking this action because the two regulations are... |