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What is accelerated approval?

Discover the latest articles, news and stories from top researchers in related subjects. Accelerated approval was established in 1992 by US Food and Drug Administration (“FDA”) regulation in response to the AIDS epidemic to address the urgency for life-saving treatments.

What is the FDA's accelerated approval process?

The FDA's Accelerated Approval program, launched in 1992, expedites the availability of new drugs that address an otherwise unmet medical need.

How has the FDA accelerated cancer drug approvals?

The FDA has speed up the pace of accelerated approvals for cancer drugs, both for their initial sales and for additional uses. Currently, the FDA is undergoing an “industry-wide evaluation” of accelerated approvals for certain oncology medicines.

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