MEDGuide and patient package inserts--again?
This article will trace the history and effects of the PPI from the time of its original concept by the FDA in the early 1970's to its current status. It will also address the response to this FDA initiative by the industry, medical community and consumer groups. Initiatives in other countries and future issues will also be discussed.
Lyons
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Arnold & Marie Schwartz College of Pharmacy, Long Island University, Brooklyn, NY, USA.
Rumore
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D003256:Community Participation; D004345:Drug Industry; D004348:Drug Labeling / Q000266:history / Q000331:legislation & jurisprudence*; D004967:Estrogens; D005260:Female; D049673:History, 20th Century; D006801:Humans; D010353:Patient Education as Topic; D011057:Politics; D014481:United States; D014486:United States Food and Drug Administration