Leveraging 505(b)(2): Real-World Evidence Rescues Program

A biotech company could not afford the time and expense of conducting studies recommended by another of its consultants and agreed to by the FDA. Through analysis of the product’s scientific and medical viability, we identified a possible alternative solution. Using our proprietary search methods, our researchers identified key publications to support the 505(b)(2) development plan.

Discover our process in assisting this sponsor in meeting its desired development cost and timeline goals.