federal_register: 2016-09366
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2016-09366 | Draft Guidances Relating to the Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products; Extension of Comment Periods | Proposed Rule | The Food and Drug Administration (FDA or the Agency) is extending the comment period for the draft guidance documents entitled "Same Surgical Procedure Exception: Questions and Answers Regarding the Scope of the Exception; Draft Guidance for Industry"; "Minimal Manipulation of Human Cells, Tissues, and Cellular and Tissue-Based Products; Draft Guidance for Industry and Food and Drug Administration Staff"; "Human Cells, Tissues, and Cellular and Tissue-Based Products from Adipose Tissue: Regulatory Considerations; Draft Guidance for Industry"; and "Homologous Use of Human Cells, Tissues, and Cellular and Tissue-Based Products; Draft Guidance for Industry and FDA Staff." The Agency is taking this action to allow interested persons additional time to submit comments and any new information. | 2016-04-22 | 2016 | 4 | https://www.federalregister.gov/documents/2016/04/22/2016-09366/draft-guidances-relating-to-the-regulation-of-human-cells-tissues-and-cellular-and-tissue-based | https://www.govinfo.gov/content/pkg/FR-2016-04-22/pdf/2016-09366.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA or the Agency) is extending the comment period for the draft guidance documents entitled "Same Surgical Procedure Exception: Questions and Answers Regarding the Scope of the Exception; Draft Guidance for Industry";... |