federal_register: 04-28579
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 04-28579 | Nonclinical and Clinical Datasets; Notice of Pilot Project | Notice | The Food and Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER), is seeking volunteers to participate in a pilot project involving the evaluation of various analysis tools to facilitate the use of electronic datasets for analysis of animal and human data submitted to FDA by applicants of biologics license applications (BLAs). These analysis tools will allow a reviewer to more efficiently capture and evaluate nonclinical and clinical datasets submitted in electronic format. | 2004-12-30 | 2004 | 12 | https://www.federalregister.gov/documents/2004/12/30/04-28579/nonclinical-and-clinical-datasets-notice-of-pilot-project | https://www.govinfo.gov/content/pkg/FR-2004-12-30/pdf/04-28579.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER), is seeking volunteers to participate in a pilot project involving the evaluation of various analysis tools to facilitate the use of electronic datasets for... |