federal_register: 02-32979
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 02-32979 | International Conference on Harmonisation; Draft Guidance on Addendum to E2C Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs; Availability | Notice | The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled "Addendum to E2C Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs." The draft guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use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 May 19, 1997 (62 FR 27470), FDA published the guidance entitled "Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs" (ICH E2C guidance), which recommends a unified standard for the format, content, and reporting frequency for postmarketing periodic safety update reports for drug and biological products. This draft guidance, an addendum to the ICH E2C guidance of May 19, 1997, provides additional information on the content and format of PSURs, including clarification of the objectives, general principles, and model for PSURs. The draft guidance is intended to help harmonize collection and submission of postmarketing clinical safety data. | 2002-12-31 | 2002 | 12 | https://www.federalregister.gov/documents/2002/12/31/02-32979/international-conference-on-harmonisation-draft-guidance-on-addendum-to-e2c-clinical-safety-data | https://www.govinfo.gov/content/pkg/FR-2002-12-31/pdf/02-32979.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Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled "Addendum to E2C Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs." The draft guidance was prepared under the auspices... |