Which is a key feature of the Prescription Drug User Fee Act?

The Prescription Drug User Fee Act (PDUFA) is significant as it was enacted to allow the U.S. Food and Drug Administration (FDA) to collect fees from pharmaceutical companies in exchange for the agency's commitment to expedite the drug approval process. This act fundamentally changed how drugs are reviewed by providing the FDA with additional resources aimed at improving the efficiency and timeliness of the review process.

By necessitating funding through user fees, PDUFA holds the FDA accountable to specific performance goals regarding the review of new drug applications. This commitment from the FDA helps ensure that pharmaceutical companies can expect a more predictable timeline for the approval of their products, promoting innovation in drug development while ensuring that safety and efficacy standards are maintained.

The other options do not accurately reflect the provisions of PDUFA. For instance, the act does not permit exclusive fee collection from a specific type of product (such as medical devices) nor does it impose restrictions based on the market capitalization of companies seeking drug approvals. Additionally, PDUFA does not eliminate clinical trials for drug approvals, as these trials are essential for establishing the safety and efficacy of new medications.