ISSN 0377-9556 (PRINT)
ISSN 2383-9457 (ONLINE)
ISSN 2383-9457 (ONLINE)
Comparison of DTx permit documents between Abilify Mycite® and Propeller Sensor®
| DTx | Abilify Mycite® | Propeller Sensor® |
|---|---|---|
| Category | Drug | Medical device |
| Approval process | NDA | 510k |
| Clinical Test | ○ | △ |
| Labeling | ○ | ○ |
| Benefit-risk Assessment | ○ | ○ |
| Prescription | ○ | ○ |
| Medication guidance | ○ | × |
| PREA | ○ | × |
NDA: New Drug Application; PREA: Pediatric Research Equity Act
△: Not required in 510k but in De novo