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FDA Announces Dates for Long-Awaited Public Hearing on Its Regulation of Off-Label Communications

Times, They Are A-Changin’ - On Wednesday, FDA announced that it will hold a two-day public hearing on November 9th and 10th to obtain input from a broad cross-section of the health care industry, including...more

Amarin/FDA Settlement: A Significant First Amendment Victory for Off-Label Marketing

On March 8, 2016, Amarin Pharma, Inc. and FDA entered into a formal settlement, close to a year after the U.S. District Court for the Southern District of New York granted a preliminary injunction against FDA’s threats to...more

A New Year’s Resolution: Avoid The Rising Tide of Defamation Claims In The Health Care Arena

In college and graduate school, we all had professors that had “non-attribution/academic freedom” policies designed to foster open debate, critical thinking and robust discussion. To state the obvious, we are a long way from...more

State Blue Sky Claims Under the Uniform Securities Act Can Be Won by Sellers, But at a Cost

An emerging tool for plaintiff-side securities litigators is the use of state claims under the Uniform Securities Act, such as Massachusetts’ so-called “Blue Sky” statute, Mass. Gen. L. c. 110A, § 410. ...more

5/23/2014  /  Securities Litigation
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