federal_register: 2019-26877
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2019-26877 | Food and Drug Administration Reauthorization Act Implementation Guidance for Pediatric Studies of Molecularly Targeted Oncology Drugs; Draft Guidance for Industry; Availability | Notice | The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "FDARA Implementation Guidance for Pediatric Studies of Molecularly Targeted Oncology Drugs." This draft guidance addresses early planning for pediatric evaluation of certain molecularly targeted oncology drugs, including biological products, for which original new drug applications (NDAs) and biologics license applications (BLAs) are expected to be submitted to FDA on or after August 18, 2020, in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act) as amended by the FDA Reauthorization Act of 2017 (FDARA). This guidance addresses the implementation of amendments made by FDARA to the FD&C Act regarding molecularly targeted oncology drugs. | 2019-12-13 | 2019 | 12 | https://www.federalregister.gov/documents/2019/12/13/2019-26877/food-and-drug-administration-reauthorization-act-implementation-guidance-for-pediatric-studies-of | https://www.govinfo.gov/content/pkg/FR-2019-12-13/pdf/2019-26877.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Drug Administration | 221,199 | The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "FDARA Implementation Guidance for Pediatric Studies of Molecularly Targeted Oncology Drugs." This draft guidance addresses early... |