federal_register: 2020-27813
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| document_number | title | type | abstract | publication_date | pub_year | pub_month | html_url | pdf_url | agency_names | agency_ids | excerpts |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2020-27813 | Interacting With the Food and Drug Administration on Complex Innovative Trial Designs for Drugs and Biological Products; Guidance for Industry; Availability | Notice | The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled "Interacting with the FDA on Complex Innovative Trial Designs for Drugs and Biological Products." The guidance provides recommendations to sponsors and applicants on interacting with FDA on complex innovative trial design (CID) proposals for drugs or biological products. FDA is issuing this guidance to satisfy, in part, a mandate under the 21st Century Cures Act (Cures Act). In accordance with the Cures Act mandate, this guidance discusses the use of novel trial designs in the development and regulatory review of drugs and biological products, how sponsors may obtain feedback on technical issues related to modeling and simulation, and the types of quantitative and qualitative information that should be submitted for review. The guidance announced in this notice finalizes the draft guidance of the same title dated September 2019. | 2020-12-17 | 2020 | 12 | https://www.federalregister.gov/documents/2020/12/17/2020-27813/interacting-with-the-food-and-drug-administration-on-complex-innovative-trial-designs-for-drugs-and | https://www.govinfo.gov/content/pkg/FR-2020-12-17/pdf/2020-27813.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 entitled "Interacting with the FDA on Complex Innovative Trial Designs for Drugs and Biological Products." The guidance provides recommendations to... |