Expedited drug approval is a regulatory process that accelerates the availability of drugs for serious conditions when they demonstrate potential to address unmet medical needs. It aims to bring promising therapies to patients faster by using mechanisms like Fast Track, Breakthrough Therapy, Accelerated Approval, and Priority Review designations.

Expedited Drug Approval

Regulatory Process

Availability of drugs

Serious conditions refer to medical or health issues that pose significant risk to an individual's well-being, potentially leading to severe complications or death if not properly managed. These conditions often require immediate attention, specialized treatment, and ongoing management to mitigate risks and improve quality of life.

Serious Conditions

Unmet medical needs refer to gaps in healthcare where current medical interventions fail to adequately prevent, diagnose, or treat diseases, leading to significant patient suffering or mortality. Addressing these needs is crucial for advancing healthcare innovation, improving patient outcomes, and ensuring equitable access to effective treatments.

Unmet Medical Needs

Promising therapies

Fast Track

Breakthrough Therapy designation is granted by the FDA to expedite the development and review of drugs intended to treat serious conditions when preliminary clinical evidence suggests substantial improvement over existing therapies. This designation aims to ensure patients have more timely access to promising new treatments that may significantly improve outcomes.

Breakthrough Therapy

Accelerated Approval is a pathway used by the FDA to expedite the approval of drugs that address unmet medical needs for serious conditions, based on surrogate endpoints that are reasonably likely to predict clinical benefit. This process allows patients earlier access to promising therapies while requiring further post-marketing studies to confirm the anticipated benefits.

Concepts

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