Latest FDA Initiatives Affecting Generic Drug Access and Pricing

April 30, 2019 8:15am

Grail Sipes
Deputy Center Director, Regulatory Policy
CDER

Maryll Toufanian
Director Office of Generic Drug Policy, CDER
U.S. Food & Drug Administration (Silver Spring, MD)

Moderator

Kurt R. Karst
Director
Hyman, Phelps & McNamara PC (Washington, DC)

  • 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