Posted by Michael Wonder on 01 Aug 2023
Stakeholders want clearer terms in FDA's generally accepted scientific knowledge guidance
31 July 2023 - Drug makers and research groups are generally supportive of the US FDA’s plan to allow greater flexibility in using generally accepted scientific knowledge (GASK) as part of regulatory applications.
However, in comments on the recent draft guidance, stakeholders asked for a clearer definition of GASK and more examples of how it could be used, with one group pushing back on the idea of having GASK take the place of certain nonclinical testing.
