Archive for August 2018

FDA and Right to Be Smoke-Free Coalition File Briefs Opposing Summary Judgment Motion in Public Health NGOs’ Lawsuit Seeking to Nullify FDA’s PMTA Filing Deadline Extension

Defendant U.S. Food and Drug Administration (FDA) and the Right to Be Smoke-Free Coalition (RSF) recently submitted briefs to the federal district court of Maryland opposing a motion for summary judgment filed by various public health NGOs in American Academy of Pediatrics v. FDA.[1]The NGOs are challenging various extensions to premarket application compliance deadlines for deemed tobacco products…

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NGOs File Motion for Summary Judgment in Lawsuit Challenging FDA’s Guidance Extending Deeming Rule Compliance Policy Deadlines

On March 27, 2018, a coalition of public health organizations including the Campaign for Tobacco-Free Kids, the Truth Initiative, the American Cancer Societyand the American Academy of Pediatrics, among others, as well as several individual physicians (collectively the “NGOs”) filed a lawsuit in the United States District Court for the District of Maryland challenging the Food and Drug…

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