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.
