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# Generally Accepted Scientific Info in NDAs/BLAs
- URL: https://www.fdaweb.com/generally-accepted-scientific-info-in-ndas-blas/
- Published: 2023-05-25T12:00:00.000Z
- Updated: 2026-09-14T18:34:15.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5154544

*Federal Register* notice: FDA is making available a draft guidance entitled “Generally Accepted Scientific Knowledge in Applications for Drug and Biological Products: Nonclinical Information.” The document is intended to assist sponsors in determining when it may be appropriate to rely on generally accepted scientific knowledge to fulfill certain legal and regulatory requirements applicable to an NDA/BLA. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2023-05-25/pdf/2023-11148.pdf?ref=fdaweb.com).