federal_register: 2022-27186
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2022-27186 | Pulmonary Tuberculosis: Developing Drugs for Treatment; Draft Guidance for Industry; Availability | Notice | The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Pulmonary Tuberculosis: Developing Drugs for Treatment." The purpose of this draft guidance is to assist sponsors in the clinical development of new antibacterial drugs for the treatment of pulmonary tuberculosis (TB). This draft guidance does not address the development of drugs for latent TB infection or for extrapulmonary TB. This draft guidance revises and replaces the draft guidance for industry of the same name published on November 6, 2013. | 2022-12-15 | 2022 | 12 | https://www.federalregister.gov/documents/2022/12/15/2022-27186/pulmonary-tuberculosis-developing-drugs-for-treatment-draft-guidance-for-industry-availability | https://www.govinfo.gov/content/pkg/FR-2022-12-15/pdf/2022-27186.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Pulmonary Tuberculosis: Developing Drugs for Treatment." The purpose of this draft guidance is to assist sponsors in the clinical... |