U.S. Generic User Fees Might Combine Inspection Visits, Boost Foreign Cooperation
This article was originally published in PharmAsia News
U.S. FDA and the generic industry are considering ideas for combining inspections to reduce the number of visits from regulators as part of user fee discussions, while industry is concerned changes could affect cooperation with foreign entities
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FDA does not want to rush, but may consider splitting negotiators into small groups to deal with specific issues.
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.
FDA, the European Medicines Agency and Australian Therapeutic Goods Administration intend to make permanent a pilot program allowing for joint facility inspections in what would be another step toward more U.S. reliance on foreign regulator and third-party data and a reduction in inspection burden.