Accelerated Approval: Getting Essential New Treatments to Patients скачать в хорошем качестве

Accelerated Approval: Getting Essential New Treatments to Patients

Since 1992, the FDA’s accelerated approval pathway has delivered more than 270 treatments to patients with life-threatening diseases who previously had limited or no treatment options. The pathway was created to address unmet medical needs of people living with HIV/AIDS and over time extended it to include cancer treatments. In 2012, Congress modernized and enhanced the pathway to expand its use for rare diseases. The pathway employs the same rigorous standard for evaluating safety and efficacy as FDA’s traditional approval. Under accelerated approval drugs are approved based on a surrogate endpoint — a metric for which the evidence demonstrates is reasonably likely to predict clinical benefit – with a post-marketing confirmatory study requirement to verify the predicted clinical benefit. Accelerated approval is one of several FDA expedited approval programs. To learn more about the pathway and the patients who have been helped by accelerated approval treatments, please visit: https://www.fightchronicdisease.org/f....