FDA, Industry Inch Closer Toward MDUFA Agreements

The FDA’s recent MDUFA counter-proposal suggests a slowly closing gap between the agency and industry negotiations.

Updated meeting minutes from May 16, present the agency’s counter-proposal, which presented two options with different levels of performance targets and associated resources needs, with an estimated $30 million difference between the two options.

FDA’s proposal included a base of $680 million plus inflation that would be raised by user fees based on current MUDFA III levels.