After several months of deliberation, the FDA has put some hard numbers to how much the proposed user fee reauthorization act (MDUFA IV) would cost. The agency has indicated the price tag of the reforms at $500 million over five years on top of the current user fee base. This does not take inflation into account.
The FDA had initially estimated it would cost and extra $456.4 million over five years. However, after more analysis the agency update the estimate according to January 27th meeting minutes.
According to an article in The Gray Sheet, the 500 million would cover all of industry’s proposals for improving the review process, including new performance goals, continuing an independent assessment of the agency’s performance, modifying some submissions processes and providing industry with time review summaries.
The FDA’s proposal includes changes to its infrastructure to account for new staff and modernizing its IT systems. The agency is putting an extra emphasis on hiring new managers and recruitment officers to improve hiring reviewers who have subject matter expertise.
The FDA also provided projected costs and provided tangible goals to improve the review process, including developing a more integrated review process, hiring review coordinators who can keep track of devices as they move through their regulatory lifespan and providing companies with review summaries of their product submissions.
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