Results 331 to 340 of about 1,036,661 (382)
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Hastings Center Report, 2009
To gain entry to the lucrative American market, newly developed drugs must be licensed by the U.S. Food and Drug Administration. Since 1975, the FDA has required applications for licensure from research studies con ducted outside the United States to comply with the Decla ration of Helsinki, one of the most influential international codes of research ...
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To gain entry to the lucrative American market, newly developed drugs must be licensed by the U.S. Food and Drug Administration. Since 1975, the FDA has required applications for licensure from research studies con ducted outside the United States to comply with the Decla ration of Helsinki, one of the most influential international codes of research ...
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New England Journal of Medicine, 2010
Approaching the end of her first year as commissioner of the Food and Drug Administration (FDA), Dr. Margaret Hamburg remarked that, despite past experience with government bureaucracies, she is struck by how hard it is to make her agency act quickly. “You feel it differently at the FDA — how long it takes to move things through the system,” she told ...
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Approaching the end of her first year as commissioner of the Food and Drug Administration (FDA), Dr. Margaret Hamburg remarked that, despite past experience with government bureaucracies, she is struck by how hard it is to make her agency act quickly. “You feel it differently at the FDA — how long it takes to move things through the system,” she told ...
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FDA’s Poly (Lactic-Co-Glycolic Acid) Research Program and Regulatory Outcomes
AAPS Journal, 2021Poly (lactic-co-glycolic acid) (PLGA) has been used in many long-acting drug formulations which have been approved by the US Food and Drug Administration (FDA).
Yan Wang +3 more
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IEEE Engineering in Medicine and Biology Magazine, 2006
This paper discusses the role of ethics in the Food and Drug Administration's approval process. The fundamental reasons for having a regulatory agency for food and medical products are ethical: concern for the safety and welfare of consumers. These basic ethical principles require a substantial number of regulations, guidances, procedures, and policies.
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This paper discusses the role of ethics in the Food and Drug Administration's approval process. The fundamental reasons for having a regulatory agency for food and medical products are ethical: concern for the safety and welfare of consumers. These basic ethical principles require a substantial number of regulations, guidances, procedures, and policies.
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GLRT-Based Adaptive Target Detection in FDA-MIMO Radar
IEEE Transactions on Aerospace and Electronic Systems, 2021This article deals with the problem of adaptive target detection in the presence of homogeneous Gaussian interference with frequency diverse array multiple-input multiple-output radar.
Lan Lan +6 more
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FDA Regulation and Approval of Medical Devices: 1976-2020.
Journal of the American Medical Association (JAMA), 2021Importance US law generally requires testing of high-risk medical devices prior to approval, as well as premarket evaluation of moderate-risk medical devices, with the goal of ensuring that the benefits of these products exceed their risks.
Jonathan J. Darrow +2 more
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European Journal of Preventive Cardiology, 2013
The Food and Drug Administration (FDA) relies upon adverse event data collected during pharmaceutical trials to evaluate the safety of medications, but these trials often fail to permit an adequate assessment of safety. The FDA usually recommends that at least 1500 patients be exposed to a new drug.
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The Food and Drug Administration (FDA) relies upon adverse event data collected during pharmaceutical trials to evaluate the safety of medications, but these trials often fail to permit an adequate assessment of safety. The FDA usually recommends that at least 1500 patients be exposed to a new drug.
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FDA Approval and Regulation of Pharmaceuticals, 1983-2018.
Journal of the American Medical Association (JAMA), 2020Importance US law requires testing of new drugs before approval to ensure that they provide a well-defined benefit that is commensurate with their risks. A major challenge for the US Food and Drug Administration (FDA) is to achieve an appropriate balance
Jonathan J. Darrow +2 more
semanticscholar +1 more source
New England Journal of Medicine, 2005
In 1992, the passage of the Food and Drug Administration (FDA) Prescription Drug User Fee Act and, in 1997, the FDA Modernization Act resulted in an 85 percent increase in the number of employees at the FDA and in more efficient processes for the approval of drugs. In this article, the author identifies the remaining challenges facing the FDA.
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In 1992, the passage of the Food and Drug Administration (FDA) Prescription Drug User Fee Act and, in 1997, the FDA Modernization Act resulted in an 85 percent increase in the number of employees at the FDA and in more efficient processes for the approval of drugs. In this article, the author identifies the remaining challenges facing the FDA.
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New England Journal of Medicine, 1996
Olestra, a polyester of sucrose and six or more triglycerides, was approved by the Food and Drug Administration (FDA) on January 24 as a nondigestible substitute for fat in snack foods, after a lon...
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Olestra, a polyester of sucrose and six or more triglycerides, was approved by the Food and Drug Administration (FDA) on January 24 as a nondigestible substitute for fat in snack foods, after a lon...
openaire +3 more sources