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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GOP Accelerated Approval Proposal Could Expand Eligibility For US FDA Pathway
The rival to House Energy and Commerce Committee Chair Frank Pallone’s bill would not set expiration dates for accelerated approvals.
PDUFA VII: US FDA Will Offer Additional Meetings To Boost Rare Disease Endpoint Development
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.
US FDA's New Drug Assessors More Experienced With Rare Disease 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.