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Approving

The FDA is on board with a proposal to speed the approval of experimental pharmaceuticals that show big treatment effects early in clinical testing.

Bob Grant
Bob Grant

Bob Grant is Editor in Chief of The Scientist, where he started in 2007 as a Staff Writer.

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WIKIMEDIA COMMONS, AYENA

Proposed legislation could allow the US Food and Drug Administration to label experimental treatments that demonstrate a sizeable impact early on in clinical trials as "breakthroughs," working with the companies that developed them to get them on the market sooner.

The FDA has already said that it supports the bill, which would give the agency the ability to speed the approval process for drugs that seem to treat life threatening illnesses like cancer and AIDS. "What happens when you have a breakthrough drug that shows an effect that's never been seen before?" Janet Woodcock, head of FDA's Center for Drug Evaluation and Research, asked reporters in March. "If we'd done business as usual during the AIDS epidemic, we would have never controlled that epidemic."

Jeff Allen, executive director of Friends of Cancer Research, told Reuters that drug companies seeking to make drugs that target deadly diseases would...

This legislation parallels the Faster Access to Specialized Treatments (FAST) Act making its way through Congress now. The FAST Act would extend the type of fast-tracked approvals already enjoyed by makers of cancer and HIV/AIDS drugs to developers of compounds that treat Parkinson’s, Alzheimer’s, diabetes, and other diseases.

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