federal_register: 2019-20494
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2019-20494 | Interacting With the Food and Drug Administration on Complex Innovative Clinical Trial Designs for Drugs and Biological Products; Draft Guidance for Industry; Availability | Notice | The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Interacting with the FDA on Complex Innovative Clinical Trial Designs for Drugs and Biological Products." The draft guidance document provides recommendations to sponsors and applicants on interacting with the FDA on complex innovative clinical trial design (CID) proposals for drugs or biological products. In accordance with the mandate under the 21st Century Cures Act (Cures Act), the draft guidance discusses the use of novel trial designs in the development and regulatory review of drugs and biological products, how sponsors may obtain feedback on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. | 2019-09-23 | 2019 | 9 | https://www.federalregister.gov/documents/2019/09/23/2019-20494/interacting-with-the-food-and-drug-administration-on-complex-innovative-clinical-trial-designs-for | https://www.govinfo.gov/content/pkg/FR-2019-09-23/pdf/2019-20494.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Drug Administration | 221,199 | The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Interacting with the FDA on Complex Innovative Clinical Trial Designs for Drugs and Biological Products." The draft guidance... |