Author Archives: Jill Wechsler

FDA Readies More Warning Letters, Fast Enforcement Action

By Jill Wechsler | Published: August 26, 2009
Image by Getty Images via Daylife FDA officials have been promising stiffer enforcement of manufacturing and marketing requirements for several months, and commissioner Margaret Hamburg is moving full-speed ahead to fulfill those predictions. Last month, FDA announced it will issue warning letters quickly when it finds violations and will require manufacturers to respond promptly. Too many [...]
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Hamburg Shifts Boxes at FDA

By Jill Wechsler | Published: July 29, 2009
Image via Wikipedia Typical of new administrations, FDA commissioner Margaret Hamburg is moving around some staff functions and bringing in new faces, but holding off on major reorganizational changes at the agency. There will be a new “food czar”—a deputy commissioner of food—but not a comparable official in charge of drugs, biologics and medical devices. Hamburg [...]
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New NIH Leader Backs Personalized Medicine

By Jill Wechsler | Published: July 22, 2009
Image by Getty Images via Daylife No one was surprised last month when the White House nominated world-famous geneticist Francis Collins for the top job at the National Institutes of Health (NIH). The driving force behind NIH’s Human Genome Project for 15 years, Collins is experienced in managing large research projects and big budgets and in [...]
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Hamburg Addresses Drug Regulation and FDA Challenges

By Jill Wechsler | Published: June 23, 2009
The new commissioner of the Food and Drug Administration is mapping plans for turning around an agency that has been demoralized and buffeted about in the press, and has lost the trust of the American people. “Our mission is to protect the health of the people, using the best available science, in as transparent ways [...]
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Daschle to Spearhead Healthcare Reform

By Jill Wechsler | Published: November 21, 2008
President-elect Barack Obama is moving quickly in selecting former Senate majority leader Tom Daschle as secretary of Health and Human Services. Daschle has been a close advisor to Obama, and now is slated to be the administration’s point person on moving health reform legislation through Congress. Reform advocates consider the selection a sign that the [...]
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