DTC Advisory Review Fee To Vary Based On Number Of Expected Submissions
Executive Summary
Under the Prescription Drug User Fee Act agreement between FDA and industry, the level of user fees for advisory review of direct-to-consumer television ads will depend on the number of ads sponsors expect to submit for review during a given year
You may also be interested in...
FDA Begins Reviewing DTC Ads As User Fee Program Faces Pay Or Die Deadline
Industry already has submitted 12 direct-to-consumer television ads to FDA for pre-review through the new DTC user fee program
FDA Begins Reviewing DTC Ads As User Fee Program Faces Pay Or Die Deadline
Industry already has submitted 12 direct-to-consumer television ads to FDA for pre-review through the new DTC user fee program
DTC Review Will Cost Industry $83,000 Per Ad Under FDA’s Final PDUFA Plan
FDA expects to charge companies $83,000 per advertisement under a pre-review program included as part of the agency's proposal for renewal of the prescription drug user fee program