This draft guidance describes instances in which it may be appropriate to rely on GASK to meet certain nonclinical safety requirements for new drug applications submitted under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 under section 351 of the Public Health Service 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. This guidance focuses on two examples of GASK that could be appropriate to fulfill certain legal and regulatory requirements applicable to the drug or biological product in question.

Notably, while the examples provided here are for illustrative purposes, determinations regarding the appropriateness of data submitted for any application, including GASK, are fact-specific, and the question of whether certain information can be considered GASK and the purpose such information would serve in an application will be considered in the context of a particular application.