Designation9 Apr 2024 23:00
Dear all just found this update
If we get the PRD designation it looks like we have until 2026 to get approved so we can get the voucher. As always this is my reading of this totally confusing procedure.
“2024 update: Rare Pediatric Disease PRV program sunset
Under the current provisions in the law, the rare pediatric disease PRV program will begin to sunset after September 30, 2024. Section 529(b)(5) of the Federal Food, Drug, and Cosmetic Act states:
(5) TERMINATION OF AUTHORITY.—The Secretary may not award any priority review vouchers [. . .] after September 30, 2024, unless the rare pediatric disease product application—
(A) is for a drug that, not later than September 30, 2024, is designated [. . .] as a drug for a rare pediatric disease; and
(B) is, not later than September 30, 2026, approved under section 505(b)(1) of this Act or section 351(a) of the Public Health Service Act.”
Come on Mike give us some good news we are all desperate for.
Thanks