federal_register: 2020-01072
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2020-01072 | Product-Specific Guidance for Levonorgestrel; Intrauterine Device; Revised Draft Guidance for Industry; Availability | Notice | The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a revised draft guidance for industry, entitled "Draft Guidance for Levonorgestrel." The revised draft guidance, when finalized, will provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for a levonorgestrel intrauterine device. | 2020-01-23 | 2020 | 1 | https://www.federalregister.gov/documents/2020/01/23/2020-01072/product-specific-guidance-for-levonorgestrel-intrauterine-device-revised-draft-guidance-for-industry | https://www.govinfo.gov/content/pkg/FR-2020-01-23/pdf/2020-01072.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a revised draft guidance for industry, entitled "Draft Guidance for Levonorgestrel." The revised draft guidance, when finalized, will provide product-specific... |