US FDA Sets User Fees For FY2021
Coronavirus Only Mentioned As Part Of PDUFA Calculation
ANDA submission rate increases, while the NDA and BLA fee drops and the biosimilar fee is unchanged.
You may also be interested in...
Pre-IND inquiries are slowing and the FDA says more late-stage development work is coming.
Syndax CEO also says US FDA’s virtual meetings would benefit from having advisory committee members on camera, which may be a technology challenge.
New drug approvals dropped, likely because of a new focus on COVID-19 treatments, while generic drug approvals increased.