Latest FDA Initiatives Affecting Generic Drug Access and Pricing
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