federal_register: E9-29991
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| E9-29991 | International Conference on Harmonisation; Draft Guidance on Addendum to International Conference on Harmonisation S6; Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals S6(R1); Availability | Notice | The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled "Addendum to ICH S6: Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals S6(R1)." The draft guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use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). The draft guidance provides recommendations on nonclinical studies to support the safety of clinical trials and marketing applications for biotechnology-derived pharmaceuticals. The draft guidance is intended to clarify and provide greater detail to the nonclinical recommendations in the ICH guidance entitled "S6 Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals" (ICH S6) published in the Federal Register of November 18, 1997 (62 FR 61515). | 2009-12-17 | 2009 | 12 | https://www.federalregister.gov/documents/2009/12/17/E9-29991/international-conference-on-harmonisation-draft-guidance-on-addendum-to-international-conference-on | https://www.govinfo.gov/content/pkg/FR-2009-12-17/pdf/E9-29991.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Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled "Addendum to ICH S6: Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals S6(R1)." The draft guidance was prepared under the auspices... |