The annual 505(b)(2) Forum will discuss the FDA NDA 505(b)(2) approval process and ideal approaches, key regulatory updates, recent court cases, and successful approaches for 505(b)(2) development.
The interest in pursuing the 505(b)(2) pathway for NDA approvals is increasing, given:
- The potential to reduce overall development time and costs by eliminating most nonclinical studies and extensive safety and efficacy tests by referencing existing data.
- The incentive of market exclusivity for up to seven years.
The range of ideal product candidates is vast and can include changes in dosage form, strength, formulation or route of administration, as well as new combination products.
Despite the increasing percentage of new small molecule drugs being approved under the 505(b)(2) process, the pathway may be viewed as complex for companies historically focused on the “traditional” pathways, like NDA 505(b)(1) or ANDA 505(j). Significant changes in small molecule development and in the generics market present a growing need for strategies in 505(b)(2) development.
The 505(b)(2) Forum will cover:
- Key factors in identifying a viable 505(b)(2) candidate
- FDA guidelines covering the 505(b)(2) pathway and recent changes
- Common mistakes associated with 505(b)(2) filings
- Examples of successful 505(b)(2) applications including fixed dose combinations, improved drug absorption, and altered route of administration
- Recent FDA regulations and court cases