federal_register: 2018-28213
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2018-28213 | Product-Specific Guidance for Linaclotide; Draft Guidance for Industry; Availability | Notice | The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a draft guidance for industry on generic linaclotide oral capsules, entitled "Draft Guidance on Linaclotide." The draft guidance, when finalized, will provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new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 linaclotide oral capsules. | 2018-12-28 | 2018 | 12 | https://www.federalregister.gov/documents/2018/12/28/2018-28213/product-specific-guidance-for-linaclotide-draft-guidance-for-industry-availability | https://www.govinfo.gov/content/pkg/FR-2018-12-28/pdf/2018-28213.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a draft guidance for industry on generic linaclotide oral capsules, entitled "Draft Guidance on Linaclotide." The draft guidance, when finalized, will provide... |