Question:

What are the goals of the FDA’s Drug Competition Action Plan?

Answer:

According to the Food and Drug Administration (FDA), the Drug Competition Action Plan (DCAP) has the goals of:

  • “Improving the efficiency of generic drug development, review, and approval processes
  • Maximizing scientific and regulatory clarity with respect to generic drugs for complex products
  • And closing loopholes that allow brand drug companies to “game” the system in ways that thwart generic competition.”

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