Nonclinical Considerations For 505(b)(2) Development Programs

As discussed in our 19 November 2020 post, applicants planning to submit a product for approval through the section 505(b)(2) new drug application (NDA) can benefit from a less costly development program with the potential for a faster route to market than a traditional 505(b)(1) program. Sponsors submitting a product through this pathway can generally plan for a nonclinical development program that is substantially curtailed compared to what is required for submission via the section 505(b)(1) stand-alone NDA pathway. Sponsors considering a 505(b)(2) submission may sometimes question whether the section 505(j) abbreviated NDA (ANDA) pathway is appropriate instead for their product. A drug that is a candidate for a section 505(j) ANDA submission [not including those under a petitioned ANDA per section 505(j)(2)(c)] is one that is identical with respect to the active ingredient(s), conditions of use, route of administration, dosage form, strength, and labeling (with some exceptions) and is bioequivalent to an FDA approved reference listed drug [1]. A 505(b)(2) application is one for which one or more of the investigations relied upon by the applicant for approval “were not conducted by or for the applicant and for which the applicant has not obtained a right of reference or use from the person by or for whom the investigations were conducted [2]. Thus, a candidate for a 505(b)(2) NDA application may include a new chemical entity (NCE) or a drug that is a change to a previously approved drug (i.e., a listed drug).