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.

Accelerated Approval

The FDA, or Food and Drug Administration, is a U.S. federal agency responsible for protecting public health by ensuring the safety, efficacy, and security of drugs, biological products, and medical devices, as well as overseeing the safety of food, cosmetics, and radiation-emitting products. It plays a crucial role in the approval process for new pharmaceuticals and medical treatments, impacting both healthcare and consumer safety standards.

Expedited approval

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

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.

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