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Reviving the FDA

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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23andMe and the FDA

New England Journal of Medicine, 2014
Because of a warning from the FDA, 23andMe has stopped marketing its personal genome service. Now, a dialogue about key issues in genomic testing could result in clear standards for the industry, including requirements for informed consent and disclosure of results.
Koichiro, Yuji   +2 more
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FDA update

Epilepsy Research, 2006
This report addresses: (1) a general update of FDA activity in areas relevant to AED development; (2) an update on issues relevant to the development of AEDs in the pediatric population; and (3) an update on the Agency's approach to the evaluation of AEDs as monotherapy.
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The FDA and Helsinki

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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The FDA controversy

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.
W H, Bachrach, A M, Connell
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PAROXETINE AND THE FDA

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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Olestra and the FDA

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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FDA finds that FDA is not biased

Chemical & Engineering News Archive, 1975
Following a year-long in-house investigation of employee allegations that the Food & Drug Administration is biased toward the drug industry, Commissioner Alexander M. Schmidt has concluded that not only is there "no evidence to support such charges," but that "there is evidence to refute them." In a 906-page report issued earlier this month, Dr ...
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FDA censorship

Clinical Pharmacology & Therapeutics, 1967
This JOURNAL has avoided criticizing the FDA for its weaknesses and its failings because we have feIt that it is charged with a virtually impossible job. Certain recent actions of the FDA, however, violate basic principles of science and education, andhere the Editor feels that in the interest of the public and of medicine he must speak.
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