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Page: << Prev | 1 | 2 The new draft guidelines eliminate both these requirements and replace remaining polices with non-binding recommendations.
"The FDA may be conceding to drug manufacturers the responsibility for regulating their own off-label marketing practices. The agency may also believe that its limited resources can be put to better or more effective use in confronting other ongoing challenges. Nevertheless, I believe that the FDA must take an active role in fostering evidence-based practice, eliminating subversion of the approval process, and requiring a balanced and fair presentation of the scientific evidence," Stafford wrote in the editorial.
Public comments on the FDA's draft guidelines are being accepted through April 21.
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-- Robert Preidt
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