FDA Considers Generic Drug User Fees

For the past year, the Food and Drug Administration (FDA) has been seeking stakeholder input, from both the public and pharmaceutical industry itself, on establishing a generic drug user fee program, similar to the other user fee programs that currently exist for prescription drugs, medical devices, tobacco products and animal drugs. The agency itself has reported problems with a backlog of generic drug applications due to scarce resources at the agency level and increasing budgetary constraints. The supplementary revenues from a new generic drug user fee program would undoubtedly allow the FDA to hire additional staff and improve the process for generic drug application review.

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