The 505(b) (2) pathway may be little-known, but it's no longer little-used. In the recent years, Indian pharmaceutical companies are increasingly using a lesser-known regulatory pathway to get new doses, formulations or combinations of drugs approved by the US FDA. 505 (b)(2), one of the most popular alternative pathway is designed to allow the approval of a drug which isn't new, but differs in several meaningful aspects.
The interactive panel discussion will highlight on how innovation can be encouraged without creating duplicates in the India generic sector.
- Reason for choosing a 505(b)(2)
- Patent/Regulatory/Medical Factors of approvals under 505 (b)(2)
- Comparison with 505(b)(1) & Litigation Challenges for 505(b)(2)
- Advantages and disadvantages of 505(b)(2)
- Some practical examples of successful 505(b)(2)