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Author Archives: Jill Wechsler
FDA Readies More Warning Letters, Fast Enforcement Action
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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 [...]
Hamburg Shifts Boxes at FDA
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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 czarâ€â€”a deputy commissioner of food—but not a comparable official in charge of drugs, biologics and medical devices. Hamburg [...]
Hamburg Addresses Drug Regulation and FDA Challenges
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 [...]
Obama Reveals Healthcare Reform Plan