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FDA's 'Critical Path' initiative could lay groundwork for expedited drug development, quality improvement

Article

As part of its Critical Path initiative, FDA has released a list reporting 76 high-priority research projects designed to modernize and advance medical product development. This program's goal is to bring medical innovations to patients more quickly and at a lower cost.

As part of its Critical Path initiative, FDA has released a list reporting 76 high-priority research projects designed to modernize and advance medical product development. This program's goal is to bring medical innovations to patients more quickly and at a lower cost.

"The goal of the initiative is to facilitate and catalyze a national effort to improve the scientific evaluative tests used to assess investigational medical products," an FDA spokesperson said.

FDA also notes in the report that Critical Path scientific evaluation tools will make product development more accurate and efficient and may also hold the promise of improving the quality of healthcare practices by making "personalized" medicine possible via the further development of biomarkers.

According to Dr Staresinic, these efforts will not pay immediate dividends but lay the foundation for future research.

"Many of the proposed innovations have yet to be developed," he said. "The timeline for many of the listed proposals is 5, 10, or even 20 years away. For example, the FDA emphasizes greater reliance on surrogate markers for product approval; the science behind many of these is in the infancy stage and is technically complex."

The Critical Path initiative may result in a boom period, with organizations bolstering their medical scientific departments through training or hiring talent that is able to interpret these new outcome measures and place the results in relative context to comparative therapies, Dr Staresinic said.

Ms Walker is senior editor of Managed Healthcare Executive, a sister publication to Formulary.

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