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联邦对处方药广告与促销的监管。

The federal regulation of prescription drug advertising and promotion.

作者信息

Kessler D A, Pines W L

机构信息

Jack D. Weiler Hospital, Albert Einstein College of Medicine, Montefiore Medical Center, Bronx, NY 10461.

出版信息

JAMA. 1990 Nov 14;264(18):2409-15.

PMID:2231998
Abstract

Prescription drug advertising has been regulated by the Food and Drug Administration since 1962. In the past decade, pharmaceutical companies have employed new communication mechanisms to reach physicians and, with increasing frequency, consumers. Examples of physician-oriented promotional activities are medical symposia and teleconferences. Consumer-oriented efforts include press conferences, use of celebrity spokespeople, and direct-to-consumer advertising. The Food and Drug Administration has asserted its legal jurisdiction over these nontraditional promotional activities and is regulating them on a case-by-case basis. As nontraditional promotional efforts become more prevalent, the Food and Drug Administration's regulatory framework must be able to meet the challenges of a changing environment.

摘要

自1962年以来,处方药广告一直受到美国食品药品监督管理局的监管。在过去十年中,制药公司采用了新的沟通机制来接触医生,并且越来越频繁地接触消费者。以医生为导向的促销活动包括医学研讨会和电话会议。以消费者为导向的活动包括新闻发布会、使用名人代言人以及直接面向消费者的广告。美国食品药品监督管理局已宣称对这些非传统促销活动拥有法律管辖权,并正在逐案对其进行监管。随着非传统促销活动变得更加普遍,美国食品药品监督管理局的监管框架必须能够应对不断变化的环境带来的挑战。

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