Do you know what GASK is? New FDA draft guidance

 GASK: Generally Accepted Scientific Knowledge is topic of a recently released (and short) FDA draft guidance (Generally Accepted Scientific Knowledge in Applications for Drug and Biological Products: Nonclinical Information).  The Introduction notes “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knowledge (GASK) may be relied on for drug or biological product approval”; which has spurred the need for the draft guidance. 

 

I like this clarifying statement on what GASK is “Generally, GASK is based on widely accepted scientific principles that are typically long-standing.”, as it ensures that knowledge has been widely tested and known, and not a recent breakthrough that has not undergone rigorous evaluation.

 

It is in the Discussion section where the best description exists for the value of GASK: the ability to not perform some nonclinical studies:

“As discussed above, in most cases, nonclinical studies provide necessary information relevant to the determination of the safety and effectiveness of a drug, or the safety, purity, and potency of a biological product, to support approval of a marketing application. In some cases, however, what is already known, for example, about a drug, the patient’s condition, or a relevant biological process (i.e., the biological context in which a drug is expected to act) in a given patient population is sufficient to confidently predict the outcome of a given nonclinical study. If there is GASK relevant to the application, it may be unnecessary for a sponsor to conduct certain nonclinical studies. This may result in streamlined product development that avoids unnecessary animal testing, decreases a drug’s development costs, and quickens the drug’s time to approval and marketing — and thus, its availability to patients.”

Two examples are given of GASK where testing would not be needed:

            -- Substances Typically Present in a Healthy Human Body (endogenous or dietary)

            -- GASK Regarding an Altered Biological Mechanism or Pathway

The draft guidance notes that these are just examples and specifies that GASK is situational and related to its use within a particular application: “Notably, while the examples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.”

 

As with all FDA draft guidance, there is an open comment period for those who would like to request clarifications or corrections to the document.