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
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.
If you are interested in having us represent you, you should call us so we can determine whether the matter is one for which we are willing or able to accept professional responsibility. We will not make this determination by e-mail communication. The telephone numbers and addresses for our offices are listed on this page. We reserve the right to decline any representation. We may be required to decline representation if it would create a conflict of interest with our other clients.
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