federal_register: 2020-27762
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2020-27762 | Dry Eye: Developing Drugs for Treatment; Draft Guidance for Industry; Availability | Notice | The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Dry Eye: Developing Drugs for Treatment." The purpose of this draft guidance is to foster greater efficiency in drug development for this disease, which currently has few effective treatment options. The goal is to enhance clinical trial data quality and to support the development of treatments for dry eye conditions. Specifically, the draft guidance provides the Agency's current recommendations regarding eligibility criteria, trial design considerations, and efficacy endpoints for use in clinical development programs of investigational drugs to treat dry eye conditions. | 2020-12-17 | 2020 | 12 | https://www.federalregister.gov/documents/2020/12/17/2020-27762/dry-eye-developing-drugs-for-treatment-draft-guidance-for-industry-availability | https://www.govinfo.gov/content/pkg/FR-2020-12-17/pdf/2020-27762.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Drug Administration | 221,199 | The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Dry Eye: Developing Drugs for Treatment." The purpose of this draft guidance is to foster greater efficiency in drug development... |