27 August 2019 - All drugs approved under the agency’s expedited programs are held to the same approval standards as other FDA drug approvals.

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.

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