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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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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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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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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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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.
openaire +2 more sources
2021
Abstract Before the 1990s, the pharmaceutical industry and the FDA were often in disagreement, and any view before then that the FDA was in the pharmaceutical industry’s pocket was off base. Lou Lasagna and William Wardell emphasized in the Journal of the American Medical Association in 1975 that it was an extraordinary perversion of ...
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Abstract Before the 1990s, the pharmaceutical industry and the FDA were often in disagreement, and any view before then that the FDA was in the pharmaceutical industry’s pocket was off base. Lou Lasagna and William Wardell emphasized in the Journal of the American Medical Association in 1975 that it was an extraordinary perversion of ...
openaire +1 more source