federal_register: 2019-26971
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2019-26971 | Product-Specific Guidance for Cocaine Hydrochloride; Nasal Solution; New Draft Guidance for Industry; Availability | Notice | The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a new draft guidance for industry, entitled "Draft Guidance for Cocaine Hydrochloride." The new draft guidance, when finalized, will provide product-specific recommendations on, among other things, the information and data needed to demonstrate bioequivalence (BE) to support abbreviated new drug applications (ANDAs) for a cocaine hydrochloride nasal solution. | 2019-12-16 | 2019 | 12 | https://www.federalregister.gov/documents/2019/12/16/2019-26971/product-specific-guidance-for-cocaine-hydrochloride-nasal-solution-new-draft-guidance-for-industry | https://www.govinfo.gov/content/pkg/FR-2019-12-16/pdf/2019-26971.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| 221,199 | The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a new draft guidance for industry, entitled "Draft Guidance for Cocaine Hydrochloride." The new draft guidance, when finalized, will provide product-specific... |