RE: Application for Pediatric Rare Disease Designation8 Nov 2023 18:53
Had a reply…..
“ The Fast Track and PRD are two separate programs, submitted to two different offices at the FDA. The voucher applies to the PRD (pediatric rare disease).
We request the voucher when we submit a rare pediatric disease product application – either in the initial package sent or up until the point of NDA/BLA filing.
Obviously the PRD is the first, necessary step which is now being prepped for review by the FDA.”
Goes on to say….
“ it is encouraging that the FDA offers these multiple accelerated approval pathways.”
I have redacted the salutations. There is no other information contained in the missive, just this clarification.
Trek