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Published by Sean P. Wajert

Mass Tort Defense

Defense of Mass Tort Claims, Class Actions, and Significant Product-Based Litigation

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Proposed Class Action Stayed Pending FDA Guidance

By Sean Wajert on July 14, 2015
Posted in Articles, Class Action, Consumer Fraud, Consumer Products, Food and Beverage

A California recently indicated he would stay a putative class action raising allegations about labeling of “evaporated cane juice” pendin…
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FDA Issues Further Nanotechnology Guidance

By Sean Wajert on July 22, 2014
Posted in Articles, Consumer Products, Food and Beverage

Late last month, the U.S. Food and Drug Administration issued one draft and three final guidance documents related to the use of nanotechnology in reg…
Continue Reading FDA Issues Further Nanotechnology Guidance

Federal Court Dismisses Cane Juice Class Under Primary Jurisdiction Doctrine

By Sean Wajert on May 23, 2014
Posted in Articles, Class Action, Consumer Products, Food and Beverage

A California federal court took a second look and decided to dismiss a proposed class action related to the ingredient “evaporated cane juice&rd…
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FDA Issues Draft Guidance on Social Media

By Sean Wajert on January 13, 2014
Posted in Articles, Drug and Device

The U.S. Food and Drug Administration recently took a small step towards providing industry with the long-awaited guidance on how pharmaceutical maker…
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CHPA Comments on Draft FDA Guidance on Nanotechnology

By Sean Wajert on August 25, 2011
Posted in Articles, Consumer Products, Drug and Device

Last week, the Consumer Healthcare Products Association (CHPA) submitted comments on the FDA’s draft guidance on nanotechnology, “Consideri…
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FDA Releases Draft Guidance on Nanotechnology

By Sean Wajert on June 13, 2011
Posted in Articles, Drug and Device, Food and Beverage, Toxic Tort

The U.S. Food and Drug Administration last week released draft guidance designed to move the process forward of providing its regulated industries wit…
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PhRMA Issues New Principles on Clinical Trials

By Sean Wajert on October 7, 2009
Posted in Articles, Drug and Device

Readers of MassTortDefense know how the conduct and results of clinical trials can reach out and affect later product liability litigation: plaintiffs…
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Device Group Comments on FDA Draft Guidance on Risk Information

By Sean Wajert on September 3, 2009
Posted in Articles, Drug and Device

Readers of MassTortDefense know how FDA regulatory treatment of advertising and promotion can impact product liability litigation involving drugs and …
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FDA Issues New Draft Guidance on Presenting Risk Information

By Sean Wajert on June 15, 2009
Posted in Articles, Drug and Device

The FDA recently issued a new draft Guidance for Industry titled “Presenting Risk Information in Prescription Drug and Medical Device Promotion.
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FDA Issues Guidance On Distribution Of Medical And Scientific Articles Regarding Off-Label Usage

By Sean Wajert on January 19, 2009
Posted in Articles, Drug and Device

The FDA has finalized guidelines for how manufacturers can distribute information to doctors about unapproved uses for drugs or medical devices. The &…
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Sean P. Wajert
Phone: 215.278.2430
Fax: 215.278.2594
Email: swajert@shb.com
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Mass Tort Defense Lawyer & Attorney Sean P. Wajert of Shook, Hardy & Bacon LLP, offering services relating to mass torts, product liability, class actions, medical monitoring, pharmaceutical litigation, consumer fraud act defense, complex litigation.

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