MedWatch Plus Stalled As FDA Prioritizes Food, Animal Drug AER System
This article was originally published in The Tan Sheet
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Key congressional leaders want to give FDA tighter control over dietary supplements, saying a Government Accountability Office report critical of the agency's enforcement supports granting additional authority
Substantive changes to FDA's MedWatch forms could come from the agency's MedWatch Plus program as soon as later this year
FDA and the National Institutes of Health are cooperating to create online portals for adverse event reporting that each agency can use to further its own current venture to improve AER quality, lower costs and reduce delivery time