By Wendy Meyeroff, Life Science Leader magazine
In 2004, the FDA unveiled a project called the Critical Path Initiative. As then Commissioner of Food and Drugs Andrew C. Von Eschenbach, M.D., later explained to Congress, “This project has the potential to transform the way medical products in the United States are designed, developed, tested, and used.”
So-named for the “critical path” medical products must travel between conception and actually reaching the patient, the initiative’s purpose is to speed that process while maintaining safety. “The FDA identified concerning trends in drug development, including rising costs, increasing timelines, and declining probability of earning approval. The Critical Path Initiative was developed as a means of reversing these trends,” says Michelle Combs, Ph.D., VP/global clinical pharmacology at MDS Pharma Services.