The 505(b)(2) new drug application (NDA) is one of three U.S. Food and Drug Administration (FDA) drug approval pathways. The pathway was created by the Hatch-Waxman Amendments of 1984, with 505(b)(2) referring to a section of the Federal Food, Drug, and Cosmetic Act. The provisions of 505(b)(2) were created, in part, to help avoid unnecessary duplication of studies already performed on a previously approved (“reference” or “listed”) drug; the section gives the FDA express permission to rely on data not developed by the NDA applicant.
The 1 Week short Certification course is designed to provided comprehensive understanding of the 505(b)(2) pathway.
Duration: 7 Days
Learning Objectives:
- Introduction to NDA
- Review the different pathway for submission
- Detailed Understanding to 505(b)(2) pathway
- Understanding of drug candidates for 505(b)(2) pathway
- Case studies on 505(b)(2) pathway
- Difference between 505(b)(2) pathway and ANDA
- 505(B)(2) review timeline
- Be able to describe experiences of others regarding real world issues associated with creating and submitting 505(b)(2) applications
- Able to use a checklist to construct a 505(b)(2) from scratch.
Who will Benefit:
- Person working in the pharmaceutical manufacturing department / F&D personnel
- Regulatory Affairs personnel
- Research and Development personnel
- Quality Assurance & Control personnel
- Development and Preparation of Submission Materials
Certification: Certificate will be provided at the end of the course after completion of the final examination.
