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Expedited Review Programs

Meaning

Expedited Review Programs are regulatory mechanisms established by agencies like the FDA to accelerate the development and review of new drugs, biologics, and devices intended to treat serious conditions and address unmet medical needs. These programs, which include designations like Fast Track, Breakthrough Therapy, and Priority Review, are designed to bring potentially life-saving or significantly advantageous therapies to patients sooner than the standard review process. They require the sponsor to demonstrate preliminary evidence of clinical benefit and involve more frequent communication and rolling submissions with the regulatory body. This process balances the need for speed with the imperative for rigorous safety and efficacy data.