What does SECT 505(b)(2) mean in FDA?
This page is about the meanings of the acronym/abbreviation/shorthand SECT 505(b)(2) in the Governmental field in general and in the FDA terminology in particular.
New drug application
A new drug application that contains full reports of investigations of safety and effectiveness but where at least some of the information required for approval comes from studies not conducted by or for the applicant and for which the applicant has not obtained a right of reference.
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