FDA Denies Public Citizen’s Request For Freeze On Opioid Approvals

By Beth Wang
September 10, 2019 at 7:16 PM
FDA denied a petition from Public Citizen that called for a moratorium on new opioid approvals until the agency’s regulation and review of opioids are revamped. The agency says it cannot impose a moratorium on the approval of new opioids because the Food, Drug and Cosmetic Act and FDA regulations require the agency to consider each application on its merits. In a press release Monday (Sept. 9), Public Citizen said FDA’s denial of the organization’s petition includes “elaborate denials” of...

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