The FDA has long used expedited regulatory paths (ERPs) to speed up the availability of promising treatments for critical illnesses. The Journal of Managed Care & Specialty Pharmacy released a study in August that looked at how these routes have changed the way colorectal cancer (CRC) is treated. CRC is the second biggest cause of cancer death in the United States. The results show that precision oncology has come a long way, but there are still big problems for payers, doctors and patients.

The FDA has four ERPs available for therapeutics, which are Fast Track Designation, Priority Review, Breakthrough Therapy Designation and Accelerated Approval. While ERPs speed access, they do so by lowering the evidentiary threshold for approval. Many CRC drugs have been cleared based on surrogat

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