In 1984, the 505(b)(2) approval pathway was created to permit FDA approve new drug applications (NDAs) based on data from previously approved drugs and therefore streamline the development and approval process of new drug applications (NDAs). The 505(b)(2) pathway is very attractive to drug makers because it can shorten their development and cost timelines. Additionally, … Continue reading Reality check on 505(b)(2) NDA Approval Pathway