Which act reauthorized the Prescription Drug User Fee Act (PDUFA)?

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Multiple Choice

Which act reauthorized the Prescription Drug User Fee Act (PDUFA)?

Explanation:
The question hinges on which law actually reauthorized the Prescription Drug User Fee Act, a program that provides FDA funding to review new drug applications. The FDA Amendments Act of 2007 is the one that reauthorized PDUFA and, in doing so, expanded the agency’s drug-safety tools (including what would become REMS) and strengthened postmarket surveillance. The other laws—FDA Modernization Act of 1997, the Family Smoking Prevention and Tobacco Control Act of 2009, and the Patient Protection and Affordable Care Act of 2010—are important FDA or health policy statutes but do not serve as the PDUFA reauthorization.

The question hinges on which law actually reauthorized the Prescription Drug User Fee Act, a program that provides FDA funding to review new drug applications. The FDA Amendments Act of 2007 is the one that reauthorized PDUFA and, in doing so, expanded the agency’s drug-safety tools (including what would become REMS) and strengthened postmarket surveillance. The other laws—FDA Modernization Act of 1997, the Family Smoking Prevention and Tobacco Control Act of 2009, and the Patient Protection and Affordable Care Act of 2010—are important FDA or health policy statutes but do not serve as the PDUFA reauthorization.

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