FDA Review Focus Areas for Value-Added Generics in 2023 – Insight 6 FDA Review Focus Areas for Value-Added Generics in 2023 – Insight 6 The approval landscape for value-added generics, including supergenerics and products utilizing the 505(b)(2) application pathway, is becoming increasingly complex. Regulatory professionals must stay adept in their understanding of FDA review focus areas to ensure successful ANDA filings. This guide provides a comprehensive, step-by-step tutorial designed for Regulatory Affairs, Market Access, and Quality Assurance professionals involved in ANDA filing consulting. Step 1: Understanding Value-Added Generics Value-added generics are drug products that provide distinct therapeutic benefits over their…