India, April 9 -- Vanda Pharmaceuticals Inc. (VNDA) has called on the U.S. FDA to withdraw a legislative proposal included in the agency's FY 2027 Congressional Budget Justification.
Proposal Details
The FDA's proposal seeks to eliminate the current legal requirement that new drug applications (NDAs) be reviewed within 180 days of filing. Instead, reviews would follow the longer timelines under the Prescription Drug User Fee Act (PDUFA) and Generic Drug User Fee Amendments (GDUFA), which typically result in 10-12 months from submission to decision. The proposal also aims to replace the formal evidentiary hearing process with a streamlined internal appeal.
Vanda's Position
Vanda argues that the change would entrench delays, reduce transp...