FDA & Regulatory
New Drug Application
A New Drug Application (NDA) is the formal request to the FDA to approve a small-molecule drug for marketing. Its acceptance sets the PDUFA review clock; biologics use the parallel Biologics License Application (BLA) instead.
- Category
- FDA & Regulatory
- Abbreviation
- NDA
Prepared research question
How does New Drug Application affect the view of a biotech company in practice?
Traceable citations · Unknowns marked
A New Drug Application (NDA) is the formal request to the FDA to approve a small-molecule drug for marketing. Its acceptance sets the PDUFA review clock; biologics use the parallel Biologics License Application (BLA) instead.
Related terms
From term to thesis rule
Investigate how New Drug Application changes a biotech thesis
Define when New Drug Application should count, block, or trigger a deeper check; BioSniper will compile that logic against available evidence.