federal_register: 2010-14036
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2010-14036 | Guidance for Industry on Bioequivalence Recommendations for Specific Products; Availability | Notice | The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled "Bioequivalence Recommendations for Specific Products." This guidance describes a new process for making available recommendations on how to design product- specific bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs). Under this process, applicants planning to carry out such studies in support of their ANDAs are able to access BE study guidance on the FDA Web site. FDA believes that making this information available on the Internet will streamline the guidance process and will provide a meaningful opportunity for the public to consider and comment on product-specific BE study recommendations. | 2010-06-11 | 2010 | 6 | https://www.federalregister.gov/documents/2010/06/11/2010-14036/guidance-for-industry-on-bioequivalence-recommendations-for-specific-products-availability | https://www.govinfo.gov/content/pkg/FR-2010-06-11/pdf/2010-14036.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 entitled "Bioequivalence Recommendations for Specific Products." This guidance describes a new process for making available recommendations on how to... |