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. Companies that have historically developed products through 505(b)(1) NDAs or ANDAs may not be familiar with the specific processes and requirements of 505(b)(2).
While some of the laws, regulations, and guidance for 505(b)(2) proposals have been published, many aspects of communication with the FDA continue to evolve, and the publication of these types of changes occurs more slowly. Mistakes due to inexperience or lack of knowledge of current processes can result in unnecessary trials being conducted, clinical holds, or the discontinuation of development due to unfounded cost concerns.
Premier Consulting has worked with sponsors who ran into trouble when they initiated 505(b)(2) projects on their own — or with consultants who were unfamiliar with 505(b)(2). In this guide, we look at three programs that have been brought to Premier Consulting for our insight on how to rectify past missteps and avoid future ones.