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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
April 19, 2017
Webinar
Related Professionals
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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May 2-3, 2024
ACI Advanced Forum on Managed Care Disputes and Litigation
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Chicago, IL
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