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Arnall Golden Gregory LLP

This is a Land of Confusion: FDA Issues Q&A Guidance on Addressing Misinformation About Medical Devices and Prescription Drugs

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In 1986, from the Invisible Touch album, the rock band Genesis sang a song about “Land of Confusion” (remember the weird video with puppets?). Almost 40 years later, in July 2024, the Food and Drug Administration issued a...more

Troutman Pepper

8 Ways Life Sciences Cos. Can Adapt to the Social Media Era

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Social media usage worldwide is showing no signs of slowing as it permeates all aspects of our daily lives. Originally published in Law360 - September 11, 2023....more

Arnall Golden Gregory LLP

FDA’s Not Dead Yet: The Agency’s OPDP Issues First Untitled Letter for 2023

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Before Comedy Central, TikTok videos, and other social media inventions, Monty Python entertained us (admittedly, an acquired taste). Many of us remember the classic scene from the 1975 movie Monty Python and the Holy Grail,...more

Skadden, Arps, Slate, Meagher & Flom LLP

Inside the Courts – An Update From Skadden Securities Litigators - May 2023

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Supreme Court Hears Argument on Traceability Requirement in Circuit-Split Slack v. Pirani - Key Points - - Before the end of June, the U.S. Supreme Court is expected to issue a decision in a high-profile securities case...more

Harris Beach PLLC

Medical and Life Sciences: Year in Review 2022

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From pharmaceuticals to toothpaste, preemption to public health, New York state and federal courts issued decisions in 2022 that further shaped the landscape in the medical and life sciences legal world. To prepare the best...more

Arnall Golden Gregory LLP

It's a Heartache: FDA's OPDP Issues an Untitled Letter for Unlawful Promotion of a Cholesterol-Lowering Drug Product

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“It’s a Heartache, Nothing But a Heartache.” Yes, the opening lyrics to Bonnie Tyler’s 1977 hit, but also what might have been felt in FDA’s Office of Prescription Drug Promotion when it issued an Untitled Letter to a drug...more

Arnall Golden Gregory LLP

Slow Down, You Move Too Fast: OPDP Issues a Warning Letter for Promoting an Investigational New Drug

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In 1966, Simon & Garfunkel sang “The 59th Bridge Song,” which opens with the lyric, “Slow down, you move too fast.” A drug company recently found out the hard way that pre-approval promotion does not leave the Food and Drug...more

Arnall Golden Gregory LLP

Freeze-Frame: FDA Issues an Untitled Letter for an Unlawful Instagram Post

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Does anyone remember the 1980’s song, “Freeze-Frame” by The J. Geils Band? A new year, a new Untitled Letter issued by the Food and Drug Administration’s Office of Prescription Drug Promotion to a prescription drug company....more

Seyfarth Shaw LLP

FDA Aggressively Monitoring and Pursuing Advertisements Touting Treatments, Preventions and Cures for COVID-19

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Companies should use caution when making efficacy claims in marketing and advertising of dietary supplements, foods, biological products and other products purported to treat or prevent COVID-19. ...more

Foley & Lardner LLP

DOJ Issues Guidelines for Enforcement Related to Off-Label Promotion

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On February 28, 2018, Ethan P. Davis, the Deputy Assistant Attorney General for the Consumer Protection Branch, addressed the life sciences community regarding off-label promotion. In his remarks, Deputy Assistant Attorney...more

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