A black-box warning for antidepressants in children?
Article Abstract:
Psychopharmacologic Drugs and Pediatric Advisory Committees of Food and Drug Administration shed light on committeeEs recent recommendations regarding the use of antidepressant medications in children and adolescents. For making such a recommendations the committee heard a number of presentation summarizing evidence that newer antidepressant drugs, primarily selective secrotonin-reuptake inhibitors, may increase suicidality in children and adolescents.
Publication Name: The New England Journal of Medicine
Subject: Health
ISSN: 0028-4793
Year: 2004
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Beyond fast track for drug approvals
Article Abstract:
The U.S. Food and Drug Administration (FDA) has introduced a series of programs, grouped under the fast-track rubric, that are designed to shorten review times and to allow for approvals at much earlier stage of clinical development of drugs. The fast-track programs, which have already facilitated earlier approval of drugs, could be expanded to encourage the use of targeted drugs in a more selective manner.
Publication Name: The New England Journal of Medicine
Subject: Health
ISSN: 0028-4793
Year: 2004
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Today's FDA
Article Abstract:
The performance of the Food and Drug Administration (FDA) in 2005 given the magnitude of its responsibility and the scope of its public trust is examined with special emphasis on the pharmaceutical industry. It was observed that the relationship between the FDA and the pharmaceutical industry is healthy, but should expand to consider the true potential of the FDA.
Publication Name: The New England Journal of Medicine
Subject: Health
ISSN: 0028-4793
Year: 2005
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