federal_register: 02-32852
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| document_number | title | type | abstract | publication_date | pub_year | pub_month | html_url | pdf_url | agency_names | agency_ids | excerpts |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 02-32852 | International Conference on Harmonisation; Draft Guidance on the M4 Common Technical Document-Quality: Questions and Answers/Location Issues; Availability | Notice | The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled "Common Technical Document-- Quality: Questions and Answers/Location Issues." The draft guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). In the Federal Register of October 16, 2001 (66 FR 52634), FDA announced the availability of an ICH guidance entitled "M4 Organization of the Common Technical Document for the Registration of Pharmaceuticals for Human Use" (M4 CTD). This draft guidance provides further clarification for preparing the quality components of an application file in the CTD format (M4Q: The CTD- Quality). The draft guidance addresses: (1) The relationship between linked sections for certain parameters (such as polymorphism and particle size), and (2) location issues (by indicating the section in which to place requested information). The draft guidance is intended to ease the preparation of paper and electronic submissions, facilitate regulatory reviews, and simplify the exchange of regulatory information among regulatory authorities. | 2002-12-30 | 2002 | 12 | https://www.federalregister.gov/documents/2002/12/30/02-32852/international-conference-on-harmonisation-draft-guidance-on-the-m4-common-technical-document-quality | https://www.govinfo.gov/content/pkg/FR-2002-12-30/pdf/02-32852.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled "Common Technical Document-- Quality: Questions and Answers/Location Issues." The draft guidance was prepared under the auspices of the International... |