federal_register: 2011-33572
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2011-33572 | Guidance for Industry: Current Good Tissue Practice and Additional Requirements for Manufacturers of Human Cells, Tissues, and Cellular and Tissue-Based Products; Availability | Notice | The Food and Drug Administration (FDA) is announcing the availability of a document entitled "Guidance for Industry: Current Good Tissue Practice (CGTP) and Additional Requirements for Manufacturers of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)" dated December 2011. The guidance document provides recommendations to establishments for complying with CGTP and additional requirements for manufacturers of HCT/Ps. The guidance is intended for any HCT/P establishment that performs a manufacturing step and is responsible for complying with CGTP requirements. The guidance also addresses whether the establishment registration and HCT/P listing requirements apply in certain instances. The guidance announced in this notice finalizes the draft guidance of the same title dated January 2009. | 2011-12-30 | 2011 | 12 | https://www.federalregister.gov/documents/2011/12/30/2011-33572/guidance-for-industry-current-good-tissue-practice-and-additional-requirements-for-manufacturers-of | https://www.govinfo.gov/content/pkg/FR-2011-12-30/pdf/2011-33572.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA) is announcing the availability of a document entitled "Guidance for Industry: Current Good Tissue Practice (CGTP) and Additional Requirements for Manufacturers of Human Cells, Tissues, and Cellular and... |