federal_register: 2021-11022
Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API
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| document_number | title | type | abstract | publication_date | pub_year | pub_month | html_url | pdf_url | agency_names | agency_ids | excerpts |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2021-11022 | FDA Reauthorization Act Implementation Guidance for Pediatric Studies of Molecularly Targeted Oncology Drugs; Guidance for Industry; Availability | Notice | The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "FDARA Implementation Guidance for Pediatric Studies of Molecularly Targeted Oncology Drugs." This 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, 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). Early pediatric evaluation of certain molecularly targeted oncology drugs as required by the FD&C Act is expected to accelerate the creation of an informed pediatric development plan and ultimately the development of promising drugs for pediatric patients. This guidance finalizes the draft guidance entitled "FDARA Implementation Guidance for Pediatric Studies of Molecularly Targeted Oncology Drugs" issued on December 13, 2019, and finalizes certain material related to implementation of FDARA that was included in the draft guidance entitled "Pediatric Study Plans for Oncology Drugs: Questions and Answers" issued on January 16, 2020. Accordingly, FDA does not intend to finalize the draft guidance entitled "Pediatric Study Plans for Oncology Drugs: Questions and Answers," which is now withdrawn. | 2021-05-25 | 2021 | 5 | https://www.federalregister.gov/documents/2021/05/25/2021-11022/fda-reauthorization-act-implementation-guidance-for-pediatric-studies-of-molecularly-targeted | https://www.govinfo.gov/content/pkg/FR-2021-05-25/pdf/2021-11022.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 "FDARA Implementation Guidance for Pediatric Studies of Molecularly Targeted Oncology Drugs." This guidance addresses early... |