505 b (2)
A Brief Overview of the 505 Regulatory Pathways
The FDA recognizes three primary pathways for the approval of new drugs and abbreviated new drug applications (ANDA): the 505(b)(1) NDA, 505(j) ANDA, and 505(b)(2) NDA. Each pathway serves a distinct purpose in the drug approval process. 505(b)(1) NDAThe 505(b)(1) NDA is a comprehensive application that relies entirely on original ... Read More
505(b)(2) Submission Process
The 505(b)(2) submission journey involves four crucial steps: candidate identification, candidate assessment, product planning, and the pre-IND meeting. Candidate IdentificationThe first step involves selecting drug products compatible with the 505(b)(2) pathway, a crucial action that mitigates the risk of failure. It typically involves a few nonclinical studies. During Phase 1, ... Read More
Whether to Submit an ANDA or 505(b)(2) Application
(1) A “stand-alone NDA” is an application submitted under section 505(b)(1) and approved under section 505(c) of the FD&C Act that contains full reports of investigations of safety and effectiveness that were conducted by or for the applicant or for which the applicant has a right of reference or use. ... Read More