Q&A: Understanding The 505(b)(2) Approval Pathway

By the time he founded Camargo Pharmaceutical Services in 2003, Ken Phelps had already amassed more than 30 years of experience in the health science and services industry. With a broad background in drug development, specifically the 505(b)(2) regulatory approval pathway, Phelps has aided in the successful FDA approval of numerous compounds. Today, his company provides a full spectrum of drug development capabilities, from pre-clinical feasibility assessments to clinical program development to regulatory review and submission.

In this Q&A, Phelps discusses 505(b)(2) — how it differs from 505(b)(1), its myriad of benefits, its continuing evolution, and its current and future impact on drug development.