Addressing 505(B)(2) Product Development Challenges Before They Become Problems

Many companies that have historically developed new products through the 505(b)(1) new drug application (NDA) pathway or generic medicines through the abbreviated NDA pathway (505(j) ANDA) may not be familiar with the specific processes and requirements of 505(b)(2). As a result, many 505(b)(2) development programs have been placed on clinical hold or otherwise disrupted because of incorrect or inadequate advice from professionals inexperienced in 505(b)(2) product development.

While much of the guidance for these processes are decades old, companies and their consultants who rely only on published guidance risk making mistakes in the process that can cost significant time and money, and even derail a project altogether.

Companies navigating the 505(b)(2) pathway do not plan on conducting the same number of clinical studies required for a 505(b)(1) submission. Instead, they leverage existing information and public data to address some of the formulation, nonclinical, clinical pharmacology, and clinical study requirements. Although noted to be one of the most attractive possibilities of 505(b)(2), it is still necessary to meet the full safety and efficacy requirements of an NDA.

In this guide, Premier Consulting provides insight on how to rectify past missteps and avoid future ones in three program examples.