What significant authority was granted to the FDA under the Pharmaceutical Drug User Fee Act V?

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The Pharmaceutical Drug User Fee Act V (PDUFA V) is designed to enhance the FDA's ability to efficiently review new drug applications by allowing the agency to collect fees from pharmaceutical companies. One of the significant authorities granted under PDUFA V is the mandate for electronic data submissions. This requirement reflects the FDA's commitment to modernizing the submission process, facilitating quicker access to necessary data, and improving the quality and consistency of the information received. Transitioning to electronic submissions streamlines the application process and helps ensure that reviews are based on comprehensive datasets, ultimately benefiting the review process and expediting the availability of safe and effective medications to the public.

The other options do not accurately represent the core authority granted under PDUFA V. For instance, while speeding up drug application processing is a goal of the act, the direct authority associated with electronic submissions is a more specific and relevant aspect.

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