Regulatory Affairs advanced
Peptide Drug 505(b)(2) Development
Development pathway for modified peptide drug products using the FDA 505(b)(2) regulatory pathway.
By Encyclopeptide Editorial | 1 min read
505b2 modified-drug regulatory reference-drug new-formulation
Overview
The 505(b)(2) pathway allows development of modified peptide drug products by referencing existing safety and efficacy data.
505(b)(2) vs ANDA
| Feature | 505(b)(2) | ANDA |
|---|---|---|
| Modification | Yes (new dosage form, | No (same as reference) |
| new route, new strength) | ||
| Studies needed | Limited new studies | Bioequivalence only |
| Exclusivity | 3 years | None |
Qualifying Modifications
- New dosage form
- New route of administration
- New strength
- New combination
- Limited changes requiring new data
Development Considerations
- Selection of reference drug
- Justification for modification
- Clinical study requirements
- Marketing exclusivity
Test Your Knowledge
Reinforce what you learned about Peptide Drug 505(b)(2) Development with interactive quizzes on Wikipept.
Take a Quiz on Wikipept