federal_register: 2020-27810
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2020-27810 | Controlled Correspondence Related to Generic Drug Development; Guidance for Industry; Availability | Notice | The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Controlled Correspondence Related to Generic Drug Development." This guidance provides information regarding the process by which generic drug manufacturers and related industry can submit controlled correspondence to FDA requesting information related to generic drug development and the Agency's process for providing communications related to such correspondence. This guidance also describes the process by which generic drug manufacturers and related industry can submit requests to clarify ambiguities in FDA's controlled correspondence response and the Agency's process for responding to those requests. This guidance finalizes the draft guidance announced in the Federal Register on November 3, 2017, and replaces the guidance for industry "Controlled Correspondence Related to Generic Drug Development" issued in September 2015. | 2020-12-17 | 2020 | 12 | https://www.federalregister.gov/documents/2020/12/17/2020-27810/controlled-correspondence-related-to-generic-drug-development-guidance-for-industry-availability | https://www.govinfo.gov/content/pkg/FR-2020-12-17/pdf/2020-27810.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 final guidance for industry entitled "Controlled Correspondence Related to Generic Drug Development." This guidance provides information regarding the process by which... |