Investment Decisions for Investors and Entrepreneurs Considering 505(b)(2) Drug Applications

How to Make Sure Your Train Is on the Fast Track

April 19, 2017


Jake M. Holdreith


Member of the Executive Board

Are you an investor or entrepreneur considering 505(b)(2) drug applications? Join Jake Holdreith, Robins Kaplan, and Ken Phelps, Camargo Pharmaceutical Services for a complimentary webinar. Jake and Ken will discuss in detail the topics listed below:

  • Does your new drug application support your legal strategy?
  • When is it likely that the FDA will treat  product as a drug/device combination?
  • What do the FDA’s pre-submission comments really mean for your application?
  • How can you predict when the FDA will ask to identify the reference listed drug in a literature based 505(b)(2) filing?

This complimentary webinar will be followed with a Q & A session.

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