Significant number of drugs on the market not yet fully approved
A large number of drug manufacturers are failing to complete the FDA’s Accelerated Approval Program, meaning not all available drugs are fully approved, finds a study.
Announcing the results of the 2026 INFORMS Board of Directors election and the new board for 2027.
INFORMS has named 12 distinguished leaders as the 2026 class of INFORMS Fellows, one of the highest honors in the profession.
Most medical devices do not hit the market through rigorous safety testing but by being deemed similar enough to something already approved—the “predicate” device through a mechanism known as the FDA’s 510(k) pathway. But similar is not a synonym for safe. While the assumption may be that substantial equivalence is a reasonable stand-in for a safety review, a share of devices cleared with this method still get recalled, and the FDA spends valuable time reviewing devices the same way, regardless of how risky it is on paper.
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A large number of drug manufacturers are failing to complete the FDA’s Accelerated Approval Program, meaning not all available drugs are fully approved, finds a study.
The Food and Drug Administration (FDA) Accelerated Approval Program was created in 1992 to considerably speed up the ability to bring certain new drugs to market. Further research to be revealed in upcoming issues of the INFORMS journal Manufacturing & Service Operations Management shows numerous drug producers are failing to finish the approval course of, meaning a significant number of drugs on the market will not be but approved.
Colorectal cancer (CRC) is the second leading cause of death due to cancer in the United States. Regular medical screening can be effective in detection and treatment, but only about 40 percent of the population is doing it. So why would people risk a potentially deadly diagnosis? Research points to significant appointment delays among some of the most effective tests, such as a colonoscopy.
CATONSVILLE, MD, August 26, 2019 – The Food and Drug Administration’s (FDA) Accelerated Approval Program was created in 1992 to significantly accelerate the ability to bring certain new drugs to market. New research published in the INFORMS journal Manufacturing & Service Operations Management reveals a large number of drug manufacturers are failing to complete the approval process, meaning a significant number of drugs on the market are not yet fully approved.
Hospitals can seem like confusing, chaotic places for patients, even when the employees are following well-established protocols and resource management techniques. But there is always room for improvement. That’s the goal behind the research of Hummy Song, Wharton professor of operations, information and decisions, who focuses on improving the performance of health care delivery systems.

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