Shortening Development And Approval Timelines For Novel Medicinal Products

The FDA and EMA offer expedited regulatory approval pathways to accelerate the development of therapies intended to treat serious conditions and unmet medical needs. We recommend that you build a strategic regulatory plan and leverage the right pathways to drive faster and more efficient drug development.

The benefits of twelve key special designations, many of which reduce clinical development and review timelines are highlighted. Overall, these regulatory pathways can save time and reduce the cost of bringing therapies to market—and to patients—sooner.