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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, $479 CD/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.
NDAs submitted under section 505(b)(2) of the FD & C Act allow sponsors to reference data that was not generated by them. This type of submission can shave years off of the development process and save millons of dollars. Attend this webinar to learn which products qualify for submissions under 505(b)(2) , data that may be referenced, content requirements, and regulatory benefit
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
Peggy J. Berry, MBA, RAC, is the President & CEO at Synergy Consulting where she provides consulting services to companies in all aspects of drug development. She also provides group and one-on-one training in drug development, regulatory affairs and project management topics.
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