Delivering Promising New Medicines Without Sacrificing Safety and Efficacy
All drugs approved under the agency’s expedited programs are held to the same approval standards as other FDA drug approvals.
https://www.fda.gov/news-events/fda-voices-perspectives-fda-leadership-and-experts/delivering-promising-new-medicines-without-sacrificing-safety-and-efficacy?utm_campaign=Delivering%20Promising%20New%20Medicines%20Without%20Sacrificing%20Safety%20and%20Efficacy&utm_medium=email&utm_source=Eloqua
The FDA walks a fine line. We must balance timely patient access to important new medicines with assuring they meet key standards. These standards exist to make sure that approved drugs have a high chance of helping those who use them. Medicines ultimately must lead to overall improvements in how patients feel, function or survive.
Not all diseases have the same impact. Getting a diagnosis of high blood pressure is not like learning that you have an incurable cancer. If your disease is serious and not well-controlled with available treatments, you may be extremely interested in how soon new medicines under development will be available. If your condition is also rare, you may be worried that no treatment will ever be found. If there are a lot of treatments available for your condition, you will want to pick the one best suited for you.
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