FDA Fast Track is a program to accelerate the development, review, and approval of new drugs to fill an unmet medical need, such as treatment for metastatic breast cancer. FDA Fast Track can help patients access new drugs earlier and help pharmaceutical companies save significant amounts of time in performing phase I, II, III, or even phase IV clinical trials for new drugs.
FDA Fast Track approval is based on limited clinical trial data. Therefore, some drugs initially approved through the FDA Fast Track program can later be suspended or withdrawn from the market due to their lack of long-term benefits or because of safety concerns.
Read more about FDA Fast Track and its impact on patients.
- FDA Fast Track
- American Cancer Society FDA’s Expedited Drug Approval Programs
- Alacrita Consulting FDA Expedited Programs for Cancer Drug Development: Don’t Believe the Doubters
- Australia Department of Health Fast-tracking of New Drugs: Getting the Balance Right