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:
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Does your new drug application support your legal strategy?
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When is it likely that the FDA will treat product as a drug/device combination?
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What do the FDA’s pre-submission comments really mean for your application?
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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.
SPEAKER:
Jake M. Holdreith
Partner,
Industry Leader, Health and Life Sciences;
Member of the Executive Board
