In recent years, there have been important advances to ensure that therapies for serious conditions are approved and available to patients as soon as sufficient data can show that the therapies’ benefits outweigh their risks. Despite the progress, there is much more work to be done. Many scientific discoveries still need to be translated into treatments while patients are urgently waiting for new life-saving therapies.

In this context, the Food and Drug Administration (FDA) has been actively scrutinizing, strengthening, and streamlining our regulatory processes at various steps along the path from drug discovery to delivery—including the clinical development phase, the longest and most expensive period of drug development. As part of this effort, we have developed and successfully used a number of flexible and innovative approaches to expedite the development and review of drugs. The vast majority of the time, the United States is the world’s first country to approve novel medicines. Just last year, the FDA approved three-quarters of the new drugs available before any other country did so.

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