NDAs submitted under FD&C 505(b)(2) are a those for which the product is not a generic nor a traditional brand. Learn the requirements for studies, reference information, and marketing requirements to take advantage of this great sponsorship opportunity.
NDAs submitted under section 505(b)(2) of the Federal Food, Drug and Cosmetic Act (FD & C) 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 benefits.
- What is a 505(b)(2) NDA
- What products qualify for submission under 505(b)(2)
- Examples of data and information that may be referenced
- Requirements for studies to be conducted
- Submission content requirements
- Limitations to and benefits of a 505(b)(2)
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