Posted by Michael Wonder on 07 Sep 2022
FDA accepts Integral Molecular's letter of intent on membrane proteome array antibody specificity test into ISTAND drug development tools pilot program
7 September 2022 - Integral Molecular has been accepted into the US FDA's ISTAND pilot program.
This program supports Innovative Science and Technology Approaches for New Drugs and was created to expand the drug development tool types listed in the 21st Century Cures legislation.
A major goal of the pilot program is to qualify these tools, thus facilitating regulatory review by allowing them to be used in regulatory applications without needing the FDA to reconsider and reconfirm their suitability.
