An Introduction to the FDA New Drug Approval Process 2012

Key Topics

• FDA`s ANDA or Generic Drug review and approval process
• FDA`s various NDA review and approval pathways
• The various elements of a full NDA, 505(b)(2) NDA and ANDA
• The difference between a "full" NDA and a 505(b)(2) NDA and an ANDA
• The costs involved with filing a drug application included required User Fees and options for obtaining Fee Waivers or Reductions
• When and how often it is necessary to meet with FDA during the review and approval process
• An overview of FDA approval times and rates
• An introduction to the differences between Phase I, Phase II and Phase III clinical testing
• Strategies for success and efficiency
• Options for Marketing Exclusivity

Who should Attend

Managers, Regulatory Affairs Professionals, Scientists, Consultants and Research Analysts.