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

FDA Law Blog

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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An Arm and a Leg: The Prescription Drug Playbook, Part I

Physician's Weekly

Bob’s journey here begins in 2019 — the first day of high school for his daughter, Mary. Claire: All of that, but the celebrity factor isn’t really what makes Cost Plus different: The company buys meds direct from manufacturers, and adds 15 percent to their wholesale cost. Dan: Another addition: Manufacturer coupons.

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Planning for the End of the COVID-19 Public Health Emergency

FDA Law Blog

It was January 31, 2020 when the Secretary of the Department of Health and Human Services (HHS) first declared the 2019 Novel Coronavirus (2019-nCoV) outbreak a public health emergency (PHE), pursuant to Section 319 of the Public Health Service Act (see here ). Before we talk about the future, let’s briefly review the history.

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