505(b)(2) Expertise With Nonclinical

Identifying the Need for Nonclinical Studies

Nonclinical/toxicology testing programs for 505(b)(2) NDA submissions are often reduced and sometimes not even required. To reference the FDA’s findings of safety and/or effectiveness for a compared Listed Drug [LD], a scientific bridge must be established between the sponsor’s drug product and the LD. This is typically done by generating clinical comparative bioavailability data. With most 505(b)(2) NDA drug products, there are differences relative to the LD. Nonclinical data with the sponsor’s 505(b)(2) drug often need to be generated or referenced to support these differences.

The 505(b)(2) NDA pathway for new drug product approval requires a careful understanding and strategic input related to designing appropriate nonclinical programs that will meet applicable regulatory requirements and be accepted by the FDA. A proposed nonclinical program is highly drug-product-dependent and requires extensive nonclinical expertise and insight to understand the potential differences between the new drug product and the LD that need to be addressed nonclinically. Because some safety endpoints cannot be readily monitored clinically, even if extensive clinical data are available, nonclinical studies might still be necessary to assess specific endpoints of concern. Overall, the 505(b)(2) NDA regulatory pathway provides mechanisms to potentially reduce the nonclinical program for a new drug product, streamline drug development and approval, and support patent protection and potential market exclusivity.

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