TypeOnline Course
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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.