The 505(b)(2) Application and the ANDA – Similarities and Differences
FDA’s 505(b)(2) Application The 505(b)(2) new drug application (NDA) is an attractive regulatory and commercial strategy for clients. This hybrid NDA application helps avoid duplicative and costly studies that others have already completed. FDA’s rules allow (b)(2) applicants to rely on this prior body of work. And because of this reliance, the (b)(2) development is […]
