Biosimilar Workload At FDA: Policy Development Far Exceeds Application Review
Even as applications themselves remain low burden, intense policy efforts put pressure on user fees.
You may also be interested in...
Mid-December kick-off meeting puts emerging user fee program on much later track than others.
New draft Q&A and three final guidances from FDA offer pros and cons for sponsors of biosimilar applications.
FDA’s fourth biosimilars-related guidance describes the formal meeting process for sponsors with products in development; the process will require extensive requests and information packages.