Michael C. Zogby

About Michael C. Zogby

Michael C. Zogby co-chairs the firm’s Products Liability and Mass Tort Group and the Pharma and Life Sciences Group. Mike is a trial lawyer who handles a variety of complex, aggregate litigation, including products liability, medical device, life sciences, class action, consumer disputes, intellectual property, trade secrets, toxic tort, multidistrict proceedings, and data collection and privacy inside and outside the United States. Read Mike's full bio

FDA’s Final Guidance on “Least Burdensome” Principles for Medical Devices

The U.S. Food & Drug Administration’s (FDA’s) Least Burdensome Provisions: Concept and Principles: Guidance for Industry and Food and Drug Administration Staff, February 5, 2019, states that “medical device regulation should be least burdensome across the total product life cycle.” This means that manufacturers are expected to provide “the minimum amount of information necessary to adequately address a relevant regulatory question or issue through the most efficient manner at the right time.” The FDA observed that this approach should “ensure that patients have access to high-quality, safe and effective medical devices.”

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Direct-to-Consumer Advertising and Promotional Labeling Transparency and Pricing Requirements for Pharmaceutical Manufacturers

Government and regulatory agencies have recently provided guidelines regarding the importance of transparency in Direct-to–Consumer (DTC) advertising through proposed regulation and guidance documents.

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FDA Warns Against Sales Representative’s “False and Misleading” Oral Statements Regarding Prescription Medicine

The U.S. Food and Drug Administration’s Office of Prescription Drug Promotion (OPDP) sent an untitled letter to Eisai Inc. on October 11, 2018, based on a sales representative’s “false and misleading” oral statements during a lunch presentation about the safety of the antiepileptic medication Fycompa®, downplaying warnings, and engaging in off-label promotion of the product.

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