NDA Classifications

CDER(Center for Drug Evaluation and Research)

1. New molecular entity

2. New Salt (not a new molecular entity)

3. New Formulation (not a new salt or a new molecular entity)

4. New combination of two or more drugs

5. New manufacturer (Duplication)

6. New indication (claim)

⇨Including switching marketing status from prescription to OTC

7. Already marketed drug products with no previously approved NDA

CBER (Center of Biologics Evaluation and Research)

  • Biological products (vaccines, serum & blood products)

  • Human cells, tissues, and cellular- and tissue-based products