federal_register: 2010-10582
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| document_number | title | type | abstract | publication_date | pub_year | pub_month | html_url | pdf_url | agency_names | agency_ids | excerpts |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2010-10582 | Guidance for Industry on Documenting Statistical Analysis Programs and Data Files; Availability | Notice | The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry <greek-i>197 entitled "Documenting Statistical Analysis Programs and Data Files." This guidance is provided to inform study statisticians of recommendations for documenting statistical analyses and data files submitted to the Center for Veterinary Medicine (CVM) for the evaluation of safety and effectiveness in new animal drug applications. These recommendations are intended to encompass the most complex data submissions to CVM, to reduce the number of revisions that may be required for CVM to effectively review statistical analyses and to simplify submission preparation by providing a uniform documentation system. | 2010-05-05 | 2010 | 5 | https://www.federalregister.gov/documents/2010/05/05/2010-10582/guidance-for-industry-on-documenting-statistical-analysis-programs-and-data-files-availability | https://www.govinfo.gov/content/pkg/FR-2010-05-05/pdf/2010-10582.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry <greek-i>197 entitled "Documenting Statistical Analysis Programs and Data Files." This guidance is provided to inform study statisticians of... |