Medical Device and Diagnostic Industry, September 17, 2015. By nominating cardiologist Robert M. Califf to be FDA’s next commissioner, the Obama Administration has taken a giant step away from the agency’s traditional avoidance of even the suspicion of coziness with the industries it regulates.
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Obama Picks Duke Physician to Head FDA
CQ Roll Call, September 15, 2015. President Obama will nominate Robert Califf to be the next commissioner of the Food and Drug Administration, the White House announced Tuesday. Califf has served as the agency’s deputy commissioner for medical products and tobacco since January. In that role, he oversees the agency’s divisions responsible for tobacco, drugs, medical devices and biological treatments, areas where the FDA is currently drafting new policies and regulations.
Read More »Michael Milken, from Junk Bonds to Legislative Advocate
Boston Globe, September 14, 2015. Not everyone is pleased with Milken’s behind-the-scenes advocacy. While supporters say the Cures Act, a version of which was passed by the House in July, would make it cheaper and faster to get cutting-edge drugs and medical devices to patients, critics warn that it would create dangerous regulatory shortcuts.
Read More »Letter to the Editor: “Patients Shouldn’t be Used as Guinea Pigs”
Sun Sentinel, September 10, 2015. We need new Alzheimer’s drugs, but we can’t assume new drugs are cures unless they are proven effective and safe.
Read More »The Facts About Addyi, Its Side Effects, and Women’s Sex Drive
Our Bodies Ourselves, September 8, 2015. It’s been almost impossible to ignore the media fascination with “pink Viagra” and the public debate about whether the drug flibanserin — soon to go sale as Addyi — should have been approved last month by the Food and Drug Administration. Find out the facts here.
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