Rare Disease Integration Into FDA Reviews Will Grow Under PDUFA VI
Stakeholders wonder about impact of placing orphan drug program staff "into review teams" as part of next iteration of user fee program.
You may also be interested in...
If they reach a public disclosure agreement, a handful of sponsors will be admitted to a new pilot program that allows four meetings with the FDA on rare disease endpoint issues.
Now most, if not all, assessment divisions within the Office of New Drugs have dealt with issues surrounding small trials and rare diseases, defying common belief that experience was spread unequally.
Attorney Frank Sasinowski says the agency should include new "boilerplate language" in official documents describing scientific flexibility for orphan drug approval requirements.