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Investment Decisions for Investors and Entrepreneurs Considering 505(b)(2) Drug Applications: How to Make Sure Your Train Is on the Fast Track

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Investment Decisions for Investors and Entrepreneurs Considering 505(b)(2) Drug Applications: How to Make Sure Your Train Is on the Fast Track

Wednesday, April 19, 2017, 1:00 P.M. CST -- 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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