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3 Hrs Webinar on 505(b)(2) NDAs By Peggy J. Berry, (Ex FDA)
Link to Website
Ticket Price: $349 One Dial-in One Attendee, $859 Group, $379 Recorded, $479CD/DVD
NDAs submitted under FD & C 505(b)(2) are a submission for which it is
Not a generic nor is it a tratitional brand. However, as such a hybrid, it is a great sponsorship opportunity. Learn the requirements for studies, reference information and marketing requirements.
What is a 505(b)(2)
What products qualify for submission under 505(b)(2) and which do not.
Examples of data that may be referenced
Requirements for studies to be conducted
Submission content requirements
Limitations to and benefits of a 505(b)(2)
Who will Benefit
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