Abbreviated New Drug Application (ANDA)
ANDAAn FDA submission for approval of a generic drug product, demonstrating bioequivalence to the reference listed drug. Does not require full clinical trials since safety and efficacy are established.
أمثلة
- Paragraph IV certification
- First-to-file 180-day exclusivity
- BE studies 90% CI 80-125%
هل تعلم؟
An FDA submission for approval of a generic drug product, demonstrating bioequivalence to the reference listed drug. Does not require full clinical trials since safety and efficacy are established.