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.

Written byBob Grant
| 1 min read

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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 ...

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Meet the Author

  • From 2017 to 2022, Bob Grant was Editor in Chief of The Scientist, where he started in 2007 as a Staff Writer. Before joining the team, he worked as a reporter at Audubon and earned a master’s degree in science journalism from New York University. In his previous life, he pursued a career in science, getting a bachelor’s degree in wildlife biology from Montana State University and a master’s degree in marine biology from the College of Charleston in South Carolina. Bob edited Reading Frames and other sections of the magazine.

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