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The Most Engaging Decision You’ll Read All Year – Five Stars

FDA Law

FDA , Petitioners, a liquid nicotine manufacturer, sued FDA arguing that the Agency was arbitrary and capricious in rejecting the Petitioner’s Premarket Tobacco Application (“PMTA”) in violation of the Administrative Procedure Act (“APA”). FDA also directed manufacturers to produce detailed marketing plans.

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Direct-to-consumer advertising distorts prescription drugs’ benefits and costs

Common Sense Family Doctor

In 1998, a Letter to the Editor in American Family Physician expressed concerns about the relatively new practice of pharmaceutical advertising directly to patients. The annual price of risankizumab is $288,000, so this is still a huge bargain for the company given the potential returns. Kennedy, Jr.’s

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FDA Announces it is Ready to Act on Menthol Cigarettes, but its Success is Uncertain

FDA Law

In 2009, Congress specifically exempted “tobacco or menthol” when it prohibited all other flavored cigarettes under the Family Smoking Prevention and Tobacco Control Act (TCA)’s “ Special Rule for Cigarettes.” Even the African American community is split on the issue of a menthol ban. Federal actions on menthol cigarettes.

IT 52
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FDA Announces it is Ready to Act on Menthol Cigarettes, but its Success is Uncertain

FDA Law

In 2009, Congress specifically exempted “tobacco or menthol” when it prohibited all other flavored cigarettes under the Family Smoking Prevention and Tobacco Control Act (TCA)’s “ Special Rule for Cigarettes.” Even the African American community is split on the issue of a menthol ban. Federal actions on menthol cigarettes.

IT 40
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Gun Violence Reduction Law Further Extends Moratorium on Trump-Era Rebate Rule

FDA Law

Kirschenbaum — We have blogged before (for example, here and here ) on amendments to the Federal health care program antikickback law safe harbor regulations that were finalized by the Trump Department of Health and Human Services in November 2020.

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