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PD UFA REAUTHORIZATION PERFORMANCE GOALS AND PROCEDURES FISCAL YEARS 2013 THROUGH 2017 I. REVIEW PERFORMANCE GOALS A. NDA/BLA Submissions and Resubmissions B. Original Efficacy Supplements C. Resubmitted

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Who needs pdufa reauthorization performance:

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Pharmaceutical companies: Pharmaceutical companies are required to submit pdufa reauthorization performance forms as part of their regulatory obligations. These forms allow them to demonstrate their compliance with performance goals set by regulatory authorities.

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Regulatory authorities: Government agencies and regulatory authorities responsible for overseeing the pharmaceutical industry utilize pdufa reauthorization performance forms to assess the performance of pharmaceutical companies. This helps in determining whether the goals and standards set by the authorities are being met.

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Healthcare professionals and organizations: Pdufa reauthorization performance forms provide valuable information about the effectiveness and safety of pharmaceutical products. Healthcare professionals and organizations may refer to these forms to make informed decisions regarding the use of specific drugs or treatments.

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What is pdufa reauthorization performance?

PDUFA reauthorization performance refers to the evaluation of the performance and effectiveness of the Prescription Drug User Fee Act (PDUFA) by the FDA.

Who is required to file pdufa reauthorization performance?

The FDA is required to file PDUFA reauthorization performance.

How to fill out pdufa reauthorization performance?

To fill out PDUFA reauthorization performance, the FDA must compile data on the review process for drug applications, user fees collected, and other relevant metrics.

What is the purpose of pdufa reauthorization performance?

The purpose of PDUFA reauthorization performance is to assess the FDA's handling of drug applications, ensure transparency, and improve the overall drug review process.

What information must be reported on pdufa reauthorization performance?

The FDA must report on metrics such as drug application review times, user fees collected, staffing levels, and other relevant performance indicators.

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