Is 505(b)(2) filing a safer strategy: avoiding a known risk?

Abstract

505(b)(2) application is one of the three established types of regulatory submission and may be advantageous for pharmaceutical sponsors. The 505(b)(2) regulatory submission is defined in FFDC act as an NDA containing investigations of safety and effectiveness, mostly relied upon by the applicant for approval of such NDA but were not conducted by or for the applicant and for which the applicant has not obtained a right of reference. In most 505(b)(2) cases, safety and efficacy information of the (RLD), both in terms of non-clinical and clinical portion, are relied upon, while minute additional data required to establish comparability with the RLD, are worked out. The present paper is an analysis on how 505(b)(2) submissions by developing different alternatives, and are considered as an effective, safer filing route in terms obtaining a approval in shorter duration, avoiding known possible risk and facilitating early launch possibility with a lower cost.