PRIA Antimicrobial Active Ingredient - Other Actions - Similarity Determination
PRIA 5 Fee Determination Decision Tree:
Antimicrobial
You selected Antimicrobial Active Ingredient - Other Actions - Similarity Determination. Please select the appropriate fee category:
| Action Code | Description |
|---|---|
| A575 | Efficacy similarity determination; determine if two products can be bridged or if only confirmatory efficacy data are needed. |
| M010 | Conditional ruling on preapplication, product substantial similarity. |