Development Resources

FDA encourages sponsors to communicate with us well before they propose clinical trials for new drugs, especially for serious diseases, rare diseases, pediatric conditions, and those for which there are limited or poor treatment options. FDA determines whether the drug is safe enough to test in humans and, if so--after all human testing is completed--decides whether the drug can be sold to the public.

Surrogate Endpoints

Page Last Updated: 08/29/2018
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