Generic User Fee Negotiations: Should Different Kinds Of ANDAs Pay More?
Executive Summary
The generic industry largely rejects one of the theoretical structures floated by FDA for an ANDA user fee program: paying more for reviews of complex drugs. But the concept does have support from many consumer advocates and at least one member of the Generic Pharmaceutical Association's board of directors, suggesting that the approach might continue to guide regulatory thinking even if it is not part of the final deal between industry and the agency.
You may also be interested in...
ANDA User Fees: Negotiators Close To Agreement, But Backlog Is Sticking Point
The generics industry does not appear satisfied with an FDA proposal to treat all applications equally under a new generic drug user fee program, preferring instead to create another, separate user fee that would clear the ANDA application backlog faster.
ANDA User Fees: Negotiators Close To Agreement, But Backlog Is Sticking Point
The generics industry does not appear satisfied with an FDA proposal to treat all applications equally under a new generic drug user fee program, preferring instead to create another, separate user fee that would clear the ANDA application backlog faster.
Generic User Fees Would Create 10-Month ANDA Review Time
Annual revenue of $250 million to $300 million in generic drug user fees is discussed as FDA unveils its "four walls and a roof" guiding principles.