The FDA has launched several new programs to help speed the approval process for new drugs, which will greatly benefit pharma companies that are working on therapies to address unmet medical needs. In addition to the well-used “fast track” designation, there are several other FDA programs companies can pursue to speed the path to market. They include obtaining “breakthrough therapy” status for drugs that address serious diseases and demonstrate clear benefits over existing therapies, and the more recent Qualified Infectious Disease Product (QIDP) designation for companies developing new antibiotics.
Pharma companies can employ several strategies for obtaining expedited approvals—including, in some cases, acquiring them from other companies. This webinar features regulatory experts from the pharma industry who can provide tips on navigating these programs.
- Understanding the differences between the various expedited approval processes and tips for figuring out which ones to pursue.
- Strategies to pursue in early development that can help companies prove to the FDA that compounds should qualify for expedited development.
- Forecasting costs and determining the potential return on investment for pursuing expedited FDA reviews.