FDA Guidance Says Some Combo Products May Qualify for PDUFA Waiver

Combination product manufacturers can cut their application user fees by as much as 50 percent if their products qualify for the "barrier to innovation" waiver established by the Prescription Drug User Fee Act (PDUFA), according to an FDA guidance.

User fees are expected to be expensive for combination products because, in many cases, manufacturers must submit two applications to the FDA -- one for each of the product's components. In cases where multiple applications are required, manufacturers have to submit user fees for both applications, as called for under PDUFA and the Medical Device User Fee and Modernization Act.

However, manufacturers can greatly reduce user fee payments if their products qualify for PDUFA's barrier to innovation waiver, which was created to ensure user fee costs don't prevent innovative products from reaching the market, according to the FDA's "Application User Fees for Combination Products" guidance.

To view the guidance, go to http://www.fda.gov/OHRMS/DOCKETS/98fr/04d-0410-gdl0002.pdf (http://www.fda.gov/OHRMS/DOCKETS/98fr/04d-0410-gdl0002.pdf).