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Click here to watch Resident Fellow Scott Gottlieb debate the hazards of the FDA on Intelligence Squared U.S. Debates.
...Efforts to restrict new technology aren’t merely the throes of a Medicare agency grappling with the fiscal woes confronting entitlements. It’s a fulfillment of the bureaucracy’s established aspirations.
On the Op Ed page of today’s Politico.com, I comment on a case that’s being heard before the Supreme Court tomorrow. It concerns drug makers and the issue of federal pre-emption of state tort claims. And it has big implications for the industry.
On Tuesday, the Supreme Court will weigh a novel legal theory being advanced by the trial bar that, if upheld, could become the torts’ next big payday against drugmakers. The case could also undermine the basic tenets of the Food and Drug Administration’s process for approving new medicines.
Another day, and we have another senior level departure from the Food and Drug Administration. The memo below — circulated this afternoon inside FDA — announced the departure of the head of the drug center’s Office of Generic Drugs, Dr. Greg Geba. It’s noteworthy that this new chief had only been in his slot for less than a year.
Several years ago, the federal government entered into a Faustian bargain with the tobacco industry — and the cigarette makers with the government. It was legislation borne of mutual antipathy.
The Food and Drug Administration is expanding its regulation of the Internet. It’s latest incursion? FDA is taking on a drug company’s use of the “Like” button on Facebook.
The announcement last night that Affymax (NASDAQ: AFFY) is recalling all lots of its red blood cell stimulating medicine Omontys could have broader implications for how the Food and Drug Administration (FDA) evaluates similar drugs going forward.
Below memo: The head of FDA’s Tobacco Center will be departing — a loss for the agency. He established himself as a fair minded, professional hand at the helm of the new center.
The Food and Drug Administration wants to regulate Internet search. At the least, searches that are mediated by regulated medical companies, and tie disease keywords to specific, regulated medical products.
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AEI’s Marilyn Ware Center for Security Studies will host General Raymond Odierno, chief of staff of the US Army, for the second installment of a series of four events with each member of the Joint Chiefs.
Please join AEI for a briefing on the TPP and the current trade agenda from 12:00 – 1:15 on Tuesday, July 30th in 106 Dirksen Senate Office Building.
Experts from the US, Europe, Canada, and Asia will address efforts to moderate housing cycles using countercyclical lending policies.












