New Legislation Seeks to Provide a Way Out for Some Companies Subject to GDUFA User Fees
Article published on FDA Law Blog, December 2013
Possible Good News for Smaller Generic Drug Manufacturers: The Small Manufacturer Protection Act of 2013 proposing to waive or reduce GDUFA fees to level the playing field to accommodate smaller companies. While the implementation of GDUFA has induced global transparency and a One World – One Quality standard that will lead to safer pharmaceuticals, incentive is needed for new and smaller companies to continue to invest in the US market.
Keep track of this legislation as it moves through the House and Senate:
H.R. 3631: Small Manufacturer Protection Act of 2013