Drug Companies Worry About New "Totality of Evidence" Standard: Is It an About-Face From the FDA on Off-Label Promotion?
نویسنده
چکیده
Drug companies worry about new FDA "totality of evidence" standard.
منابع مشابه
Promotion of Drugs for Off-label Uses: The US Food and Drug Administration at a Crossroads.
Since 1962, the US Food and Drug Administration (FDA) has required companies to establish, with adequate and well-controlled clinical trials, a drug’s safety and efficacy for each intended use and has prohibited the “offlabel” promotion of drugs. For companies to market an approved medicine for new indications, they must first conduct trials and submit data to establish safety and efficacy, as ...
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on YouTube about using one of its products and the content prompts questions about off-label use, this would be a solicited request. The FDA may consider solicited requests evidence of a firm’s intent that a drug be used for off-label purposes. 2. The guidance also distinguishes between non-public and public unsolicited requests and recommends appropriate responses. For example, a telephone cal...
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The adoption and use of digital forms of direct-to-consumer advertising (also known as “eDTCA”) is on the rise. At the same time, the universe of eDTCA is expanding, as technology on Internet-based platforms continues to evolve, from static websites, to social media, and nearly ubiquitous use of mobile devices. However, little is known about how this unique form of pharmaceutical marketing impa...
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ورودعنوان ژورنال:
- P & T : a peer-reviewed journal for formulary management
دوره 42 5 شماره
صفحات -
تاریخ انتشار 2017