USA FDA Rare Disease Endpoint Advancement (RDEA) Pilot Program Public Workshop( Catapult’s regulatory round-up May)

The FDA is establishing a Rare Disease Endpoint Advancement (RDEA) Pilot Program to support novel endpoint efficacy development for drugs that treat rare diseases. The RDEA Pilot Program fulfills a commitment under the Prescription Drug User Fee Act (PDUFA VII).

Academic investigators, pharmaceutical and biotechnology companies, patient advocacy organizations, and anyone interested in developing rigorous endpoints for rare disease drug development are encouraged to attend.

A workshop will be held on 7-8 of June 2023. Further details including how to register can be found here.

Published on the 2nd of June 2023. Read the entire regulatory round-up for the month of May published and curated by Catapult here.