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.”