The FDA is committed to working with drugmakers to bring critical drugs to patients as fast as possible, writes Dr. Karen Midthun, director of the FDA Center for Biologics Evaluation and Research. The agency worked closely with the CDC to make an unapproved meningitis vaccine accessible to colleges afflicted by outbreaks, she writes. The FDA has regulatory tools, including the expanded access program, to make effective and innovative treatment options accessible to patients with serious conditions, she writes.

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