The Importance Of Fast Track Designation

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Accelerated Pathways (APs) for the development of new drugs in the U.S., Europe, and Japan are intended to bring needed and important new treatments to patients more quickly which have multiplied in recent years and have proven to present opportunities and benefits for patients and developers (Parexel, 2016). Accelerated Approval (AA) was created by FDA regulation in 1992, in response to the emergence of the AIDS epidemic (Health Affairs, 2017). It was codified by the FDA Safety and Innovation Act (FDASIA) in 2012 (Health Affairs, 2017). Using AA, the FDA may grant approval for a new drug that offers a significant benefit compared to available therapies for serious medical conditions where there is unmet medical need, based on preliminary…show more content…
In general, the preliminary clinical evidence should show a clear advantage over available therapy (FDA, 2015). Accelerated Approval can sometimes take many years to learn whether a drug actually provides a real effect on how a patient survives, feels, or functions when studying a new drug (FDA, 2015). A positive therapeutic effect that is clinically meaningful in the context of a given disease is known as clinical benefit (FDA, 2015). Mindful of the fact that it may take an extended period of time to measure a drug’s intended clinical benefit, in 1992 FDA instituted the Accelerated Approval regulations (FDA, 2015). These regulations allowed drugs for serious conditions that filled an unmet medical need to be approved based on a surrogate endpoint (FDA, 2015). Using a surrogate endpoint enabled the FDA to approve these drugs faster (FDA, 2015). Priority Review will direct overall attention and resources to the evaluation of applications for drugs that, if approved, would be significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications (FDA, 2015). Prior to approval, each drug marketed in the United States must go

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