有哪些信誉好的足球投注网站- 1、本文档共21页，可阅读全部内容。
- 2、有哪些信誉好的足球投注网站（book118）网站文档一经付费（服务费），不意味着购买了该文档的版权，仅供个人/单位学习、研究之用，不得用于商业用途，未经授权，严禁复制、发行、汇编、翻译或者网络传播等，侵权必究。
- 3、本站所有内容均由合作方或网友上传，本站不对文档的完整性、权威性及其观点立场正确性做任何保证或承诺！文档内容仅供研究参考，付费前请自行鉴别。如您付费，意味着您自己接受本站规则且自行承担风险，本站不退款、不进行额外附加服务；查看《如何避免下载的几个坑》。如果您已付费下载过本站文档，您可以点击 这里二次下载。
- 4、如文档侵犯商业秘密、侵犯著作权、侵犯人身权等，请点击“版权申诉”（推荐），也可以打举报电话：400-050-0827(电话支持时间：9:00-18:30)。
查看更多
Regulating ConsumerDirected Rx Drug Promotion：调节消费者定向RX药品促销
An Overview of Direct-to-Consumer Prescription Drug Promotion Nancy M. Ostrove, Ph.D. Risk Communication Advisory Committee May 15, 2008 DTC an Evergreen Issue May 8, 2008 Hearing House Energy Commerce Subcommittee on Oversight and Investigations Testimony from researchers, AMA, GAO, Merck/Schering-Plough, Ortho Biotech, Pfizer Web cast and prepared testimony at: /cmte_mtgs/110-oi-hrg.050808.DTC.shtml Regulatory Oversight Oversight of drug promotion is split 1962 Kefauver-Harris amendments to Federal Food, Drug, and Cosmetic Act (FFDC Act) agreement with Federal Trade Commission FTC has primary jurisdiction over OTC drug advertising FDA has primary jurisdiction over Rx drug labeling and advertising; also over OTC drug labeling Background Facts - 1 Until FDAAA, the FFDC Act did not distinguish between advertising to health care professionals and advertising to patients or consumers Currently, implementing regulations (21 CFR 202.1) do not distinguish between advertising to health care professionals and advertising to patients or consumers That is, the underlying rules historically have been the same regardless of audience Background Facts - 2 Promotion directed toward consumers was never prohibited – practice changed FFDC Act generally prohibits any require-ment for preclearance of advertising except in “extraordinary circumstances” FFDC Act requires advertisements to include “information in brief summary” about product risks and benefits Classes of Promotional Materials - 1 Different classes of promotional materials Labeling (of the promotional variety) brochures, mailing pieces, literature, detail aids, price lists, calendars, and “similar pieces of printed, audio, or visual matter descriptive of a drug,” and references (e.g., PDR) Classes of Promotional Materials - 2 Advertisements in journals, magazines, newspapers, other periodicals or through broadcast media (TV, radio, telephone communications systems) Different types of advertisements have different reg
文档评论（0）