How to Use 505(b)(2) to Achieve Commercial Success

How to Use 505(b)(2) to Achieve Commercial Success will benefit executives at Biotech and Pharmaceutical companies interested in learning more about 505(b)(2) drug development, which enables a lower cost, lower risk, and faster path to regulatory approval and market. When properly executed, 505(b)(2) drug development averages 3.5 years and $20 Million to NDA approval in comparison to 11.5 years and $2.6 Billion for 505(b)(1) drug development to NDA approval.

Focusing on high-level strategies, this webinar will clarify common misconceptions associated with 505(b)(2) drug development and emphasize benefits of 505(b)(2), including:

  • Why 505(b)(1) guidance cannot be applied in 505(b)(2) and results in a clinical hold
  • Why the Pre-IND meeting provides the crucial link to a successful 505(b)(2) NDA
  • Reference Listed Drug (RLD) – why it isn’t necessary or required
  • How a 505(b)(2) NDA differs from a 505(b)(1) NDA
  • Which clinical studies are / are not necessary for 505(b)(2


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