MDUFA


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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New Report Details What Should Happen When Scientists at FDA Disagree

, former science policy fellow

Should scientists at the Food and Drug Administration be able to have honest disputes with their colleagues about the science behind a drug or medical device approval decision? Or should they keep quiet about their concerns, preferring not to rock the boat? Read more >

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For Sara, Faulty Medical Device Leads to Unnecessary, Invasive Surgery

, program manager, Center for Science & Democracy

Along with Gwen, Elsa, and Henry, another UCS supporter shared his family’s experiences with unsafe drugs and medical devices: John M’s daughter, Sara, has had needless complications with medical devices in her heart. Read more >

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The Human Cost of FDA Decisions: A Faulty Hip Replacement Disrupts a Young Man’s Life

, program manager, Center for Science & Democracy

After sharing the personal experiences of two separate UCS supporters—Gwen and her mother, Maxine and Elsa and her husband, Dan–with drug and device safety, I’ve heard from others who are also brave enough to share their stories with us. Henry H.’s tale about his metal on metal hip replacement is particularly touching, showing how a faulty medical device can have consequences not just for the victim but for his entire family. 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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