federal_register: 2012-30308
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2012-30308 | Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence Recommendations; Availability | Notice | The Food and Drug Administration (FDA) is announcing the availability of additional draft and revised draft product-specific bioequivalence (BE) recommendations. The recommendations provide product-specific guidance on the design of BE studies to support abbreviated new drug applications (ANDAs). In the Federal Register of June 11, 2010, FDA announced the availability of a guidance for industry entitled "Bioequivalence Recommendations for Specific Products," which explained the process that would be used to make product-specific BE recommendations available to the public on FDA's Web site. The BE recommendations identified in this notice were developed using the process described in that guidance. | 2012-12-17 | 2012 | 12 | https://www.federalregister.gov/documents/2012/12/17/2012-30308/draft-and-revised-draft-guidances-for-industry-describing-product-specific-bioequivalence | https://www.govinfo.gov/content/pkg/FR-2012-12-17/pdf/2012-30308.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA) is announcing the availability of additional draft and revised draft product-specific bioequivalence (BE) recommendations. The recommendations provide product-specific guidance on the design of BE studies to... |