Latest FDA Initiatives Affecting Generic Drug Access and Pricing

April 30, 2019 8:15am

What is it about?

  • Analyzing the status and findings of the FDA’s internal working group on Generic Competition
  • Understanding the new priority ANDA review category
  • Examining Commissioner Gottlieb’s efforts to encourage generic approval
    • Drug Competition Action Plan
  • Assessing GDUFA II negotiations and the effort to assist potential ANDA applicants for complex products
  • Explaining user fee changes in PDUFA VI