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THE US Food and Drug Administration (FDA) has released a draft "concept paper" on guidelines for pharmaceutical company support of scientific or educational programs.
The FDA has been requesting comments on the proposed guidelines from industry, medical educators, and other interested parties.
According to Dennis K. Wentz, MD, director of the American Medical Association's (AMA) Division of Continuing Medical Education and chair of the Ad Hoc Task Force on Industry-Continuing Medical Education (CME) Provider Collaboration—which includes representatives from the AMA, the Accreditation Council for Continuing Medical Education (ACCME), the pharmaceutical industry, and now observers from the FDA—the task force met last month and will meet again next week (December 12) to discuss the FDA's draft concept paper. It also will examine a proposal, by the pharmaceutical industry's Fred W. Lyons, Jr, to create a self-regulating system.
Similar to ACCME, AMA
The proposed FDA guidelines are not very different from the
Skolnick AA. FDA Issues Draft 'Concept Paper' on Drug Company Funding of CME. JAMA. 1991;266(21):2947–2948. doi:10.1001/jama.1991.03470210013004
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