ANDA User Fees: Industry Takes Holistic Approach, Wants Whole New Office
The generics industry is pushing FDA to create a commissioner-level office dedicated to handling issues related to ANDAs during negotiations over the creation a user fee program for generic drugs
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Coalition and GPhA expect to be on the same page at FDA public meeting, but Mylan proposes alternative user fee structure based on establishment fees.
FDA has long negotiated its brand user fee program with two distinct but closely aligned industry groups: the Pharmaceutical Research and Manufacturers of America and the Biotechnology Industry Organization. Now the agency will be using those same discussion techniques as it develops the generic drug user fee program.
FDA seeks comments at Sept. 17 public hearing on issues surrounding development of an ANDA user fee program, including whether applications for more complex products should carry a higher fee and whether fees should be used to support postmarketing safety oversight.