PDUFA


We Found Independent Experts—the FDA Can Too

, program manager, Center for Science & Democracy

Pharmaceutical and medical device companies, and some in Congress, argue that it’s difficult to find independent experts to serve on FDA’s scientific advisory committees due to strong financial conflict of interest standards.

Our experience proves otherwise. Read more >

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Study: FDA is Faster than Europe, Canada in Drug Approvals

, program manager, Center for Science & Democracy

In the New England Journal of Medicine this week, scientists from Yale University published research finding that the Food and Drug Administration approves drugs faster than its counterparts in Canada and Europe. (Media coverage is here and here.) The study reinforces the fact that FDA can approve drugs with relative speed while putting the safety of Americans first. Read more >

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The Human Cost of FDA Decisions: For Dan and Elsa, Life Depends on Safe Medical Devices

, program manager, Center for Science & Democracy

Yesterday, I shared the story of a UCS supporter whose family had experienced tragic consequences when unsafe drugs were allowed on the market. But drugs and medical devices, when adequately tested and monitored, do have the potential to vastly improve one’s health. For Dan O. of Norwalk, CT, medical advances in the treatment of the coronary system have been lifesaving.

Read more >

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The Human Cost of FDA Decisions: For a Midwestern Family, A Breakdown in Drug Safety Hits Home

, program manager, Center for Science & Democracy

The consequences of unsafe drugs and medical devices are real—and nobody knows that better than Gwen B. of West Sacramento, California. We talked a few days ago after she responded to a UCS action alert with a story about her mother, Maxine, and I was moved enough to want to share her family’s story with you. Read more >

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New Allegations of Political and Corporate Pressure on FDA

, program manager, Center for Science & Democracy

In today’s New York Times, Gardiner Harris describes tensions between the FDA, Congress and the White House regarding the agency’s attempts to inform and protect the public. It’s an incredible article that helps demonstrate the pervasiveness of both political and corporate pressure on the agency, and how those who do not have scientific training in public health attempt to take decision-making authority on what should be scientific issues away from those who do.

Read more >

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