FDA Guidance: Cooperation Needed to Create Drug Development Tools

Sponsors should work together to get FDA qualification for drug development tools (DDTs), which can then be used to aid in the development and review of multiple companies’ drugs, a new draft guidance advises. Once a DDT is qualified, CDER will publicize the qualification determinations and then sponsors can use the DDT without requesting that CDER reconfirm its suitability, the Oct. 22 guidance says. Comments on the guidance are due Jan. 24.
Clinical Trials Advisor