The 505(b)2 development pathway is designed for companies to perform a streamlined developmental path for already approved drugs on the market that are seeking approval utilizing a new formulation, route of administration, or dosing regimen. A hybrid approach between a traditional new drug application (NDA) and an abbreviated NDA (ANDA), this designated pathway simplifies the process for companies by allowing referencing of already available information related to the currently approved and marketed reference drug. In many cases, companies can avoid much of the cost and intensive preclinical and clinical safety and efficacy testing.
Companies face challenges, however, in navigating the process and understanding what new data may be needed, which new studies must be conducted, and which data is acceptable from previously presented evidence. Utilizing innovative approaches to the 505(b)2 pathway can save companies time, money, and resources in developing their new product. This webinar will examine the benefits and challenges associated with the 505(b)2 pathway and how innovative solutions and planning in the early stages of development can help support a more streamlined and faster pathway towards approval.