505(b)(2) Expertise With The Regulatory Pathway

Overcoming 505(b)(2) Complexities

505(b)(2) NDAs typically consist of changes to a previously approved NDA drug product. A 505(b)(2) NDA contains full safety and effectiveness reports but allows at least some of the information required for NDA approval, such as safety and efficacy information on the active ingredient, to come from studies not conducted by or for the applicant.

Clinical development for 505(b)(2) programs is highly drug product-dependent and requires extensive regulatory and clinical expertise and insight to understand the differences between the new drug product and the listed drug and how to strategically leverage the published literature.

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