Generally accepted scientific knowledge: FDA explains how it applies to nonclinical data in drug apps
Following an “increasing number of questions” on the extent to which generally accepted scientific knowledge (GASK) may be relied on by the FDA as part of approval decisions, the agency today put out a new, 6-page draft guidance on the topic of GASK, with examples of when it might be used appropriately.
In certain cases where GASK applies to an NDA or BLA, FDA says it may be unnecessary for a sponsor to conduct certain nonclinical studies, which saves them time, and the FDA notes, “decreases a drug’s development costs.” The draft defines GASK as “medical or scientific information that is generally accepted by experts qualified by scientific training and experience in the relevant field,” and the agency points to two specific examples of where GASK was actually used to meet relevant approval requirements.
To read Endpoints News become a free subscriber
Unlock this article instantly, along with access to limited free monthly articles and our suite of newsletters