Generally Accepted Scientific Knowledge in Applications for Drug and Biological Products: Nonclinical Information May 2023
Not for implementation. Contains non-binding recommendations.
This guidance is being distributed for comment purposes only.
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Guidance Issuing OfficeCenter for Drug Evaluation and ResearchCenter for Biologics Evaluation and Research
FDA has received an increasing number of questions regarding the extent to which generally accepted scientific knowledge (GASK) may be relied on for drug or biological product approval. This guidance describes instances in which it may be appropriate to rely on GASK to meet certain nonclinical safety requirements for new drug applications (NDAs) submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(b)) and biologics license applications (BLAs) under section 351 of the Public Health Service Act (PHS Act) (42 U.S.C. 262(a)). The information that supports the nonclinical safety of a drug and that must be submitted in the application can include references to GASK, when appropriate, instead of or in addition to, specific studies conducted with respect to the drug. In such cases, therefore, it might be unnecessary to conduct certain nonclinical studies.