Just In! FDA Releases Two New Pilot Programs

Written by Genna Jenkins, Project Associate, Regulatory Affairs, Halloran Consulting Group

FDA recently revealed their two newest pilot programs – Rare Disease Endpoint Advancement (RDEA) and the Split Real Time Application Review (STAR). The RDEA Pilot Program is designed to encourage efficacy endpoint development of novel drugs for the treatment of rare diseases whereas the STAR Pilot Program seeks to shorten the length of time between the date of complete submission and action date, authorizing earlier patient access to therapies targeting an unmet medical need.

Sponsors should expect the opening of applications to RDEA in the fourth fiscal quarter of 2023 with an acceptance of one application per fiscal quarter through 2027. Applicants may apply to STAR in two parts, two months apart, and with an FDA review beginning upon the receival of the Part 1 Submission and initiation of the PDUFA review clock upon receival of the Part 2 Submission.

The FDA will consider applicants eligible for the new pilot programs only if they meet particular criteria, and there is a lot to manage. Please contact us to further discuss the timing, eligibility criteria, and submission process.

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