Margaret Hamburg news and information

Air filters marked with dark-amber stains, unexplained variations in drug purity, patients' complaints dismissed without investigation: all were among the deficiencies cited at 31 drug-compounding factories inspected in the past seven weeks by the Food and Drug Administration.
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Air filters marked with dark-amber stains, unexplained variations in drug purity, patients' complaints dismissed without investigation: All were among the deficiencies cited at 31 drug-compounding factories inspected in the past seven weeks by the Food and Drug Administration.
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The method for mixing drugs that led to 53 deaths in an outbreak of fungal meningitis in 20 states last fall is inherently risky, but seldom-used by hospitals.
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Modern Healthcare's Top 25 Women in Healthcare recognition program honors exceptional female healthcare executives who are making a positive difference in the industry. See who made this year's list, presented in alphabetical order
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Lawmakers and mobile health advocates plan to address how the Food and Drug Administration should regulate mobile health technologies, such as smartphones and mobile medical apps that are increasingly being used for health-related reasons.
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The trade in illegitimate medications is a global public health problem that requires a global solution, according to a nearly 300-page report from the Institute of Medicine.
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Following are the titles and affiliations for the 100 nominees for Modern Healthcare's 50 Most Influential Physician Executives in Healthcare for 2013.
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In one of the few pieces of significant legislation to win bipartisan support in 2012, Congress reauthorizes the Food and Drug Administration's user-fee acts for the drug and medical device industries and establishes first-time user-fee programs for the biosimilars and generic drug sectors.
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Officials from state pharmacy boards repeatedly told members of the FDA that they need clarification on the definition of a nontraditional compounding pharmacy.
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Federal lawmakers, government health officials and health-system pharmacists want clearer policies to determine who should regulate the large-scale compounding pharmacies such as the one blamed for a deadly fungal meningitis outbreak that has left 33 dead.
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