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.
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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.
As more sponsors begin using RWE, the agency is establishing procedures and training to ensure assessors consistently apply policies.