federal_register: 00-33369
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 00-33369 | International Conference on Harmonisation; Guidance on Q6A Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances | Notice | The Food and Drug Administration (FDA) is publishing a guidance entitled "Q6A Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances." The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance describes or provides recommendations concerning the selection of test procedures and the setting and justification of acceptance criteria for new chemical drug substances and new drug products produced from them. The guidance is intended to assist in the establishment of a single set of global specifications for new drug substances and new drug products. | 2000-12-29 | 2000 | 12 | https://www.federalregister.gov/documents/2000/12/29/00-33369/international-conference-on-harmonisation-guidance-on-q6a-specifications-test-procedures-and | https://www.govinfo.gov/content/pkg/FR-2000-12-29/pdf/00-33369.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA) is publishing a guidance entitled "Q6A Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances." The guidance was prepared under the auspices of... |