Results 301 to 310 of about 914,390 (333)
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New England Journal of Medicine, 2015
The FDA has recommended a pathway to expedite completion of studies to ensure that new sunscreen ingredients are safe and effective. A renewed commitment to collaboration on high-quality studies could lead to breakthroughs in melanoma prevention.
Stephen Ostroff, Robert M. Califf
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The FDA has recommended a pathway to expedite completion of studies to ensure that new sunscreen ingredients are safe and effective. A renewed commitment to collaboration on high-quality studies could lead to breakthroughs in melanoma prevention.
Stephen Ostroff, Robert M. Califf
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The American Journal of Digestive Diseases, 1977
Carbenoxolone, cimetidine, and chenodeoxycholic acid are unavailable in the United States. Other pharmacologic agents such as lactulose and pentagastrin have recently become available, but only many years after they were demonstrated to be both safe and effective.
Alastair M. Connell, William H. Bachrach
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Carbenoxolone, cimetidine, and chenodeoxycholic acid are unavailable in the United States. Other pharmacologic agents such as lactulose and pentagastrin have recently become available, but only many years after they were demonstrated to be both safe and effective.
Alastair M. Connell, William H. Bachrach
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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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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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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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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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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...
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Journal of the American Academy of Child & Adolescent Psychiatry, 2004
On June 19, 2003 the U.S. Food and Drug Administration (FDA) released a statement regarding the antidepressant Paxil® for pediatric depression. The primary reason for the statement was new data indicating a possible increased risk of suicidal thinking and suicidal attempts in children and adolescents under the age of 18 treated with the drug Paxil for ...
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On June 19, 2003 the U.S. Food and Drug Administration (FDA) released a statement regarding the antidepressant Paxil® for pediatric depression. The primary reason for the statement was new data indicating a possible increased risk of suicidal thinking and suicidal attempts in children and adolescents under the age of 18 treated with the drug Paxil for ...
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2021
The US Food and Drug Administration (FDA) has existed for more than 150 years, traced back to the creation of the Agricultural Division in 1848. Although the mission and infrastructure of the FDA have evolved to a great extent, the basic principle has remained the same – to protect the public health.
Katie McCarthy, Niki Gallo
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The US Food and Drug Administration (FDA) has existed for more than 150 years, traced back to the creation of the Agricultural Division in 1848. Although the mission and infrastructure of the FDA have evolved to a great extent, the basic principle has remained the same – to protect the public health.
Katie McCarthy, Niki Gallo
openaire +2 more sources