The FDA in a Post-Gottlieb World - Webinar Recording/Transcript
The FDA in a Post-Gottlieb World: Gottlieb’s Accomplishments, New Policies — and a Look Ahead
The FDA’s leadership is changing and it’s time to take a look at what’s ahead for you.
Join us for a detailed analysis about whether the changes and reforms advanced in the past two years will remain and whether it will affect your product development and approval applications.
- Policy decisions on generic drug approvals
- Reorganization of the Office of New Drugs
- Changes in orphan drug policy
- New initiatives dealing with the effort to reduce drug prices
- Further changes in FDA’s policies on advertising and promotion regulation
- Changes in FDA standards for clinical trials
Gain an expert perspective on the Gottlieb years, the key issues addressed, regulations and guidances issued, and the way that these issues will be handled in the future.