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FTC workshop highlights potential changes to agency’s review of pharmaceutical mergers

On June 14 and 15, 2022 the Federal Trade Commission (FTC) hosted a workshop titled “Future of Pharmaceuticals: Examining the Analysis of Pharmaceutical Mergers.” The...

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Proof in Trial: Appellate Edition: Integra Med Analytics LLC et al. v. Providence Health & Services et al.

What happens when a company is unfairly accused of defrauding the U.S. government? In this case, a medical record software company was caught in the crosshairs of a business created for the ...

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Restrictions on lawyer ads involving drugs and medical devices are not unconstitutional, says federal court

The Fourth Circuit has found that a West Virginia state law restricting how attorneys can solicit clients in pharmaceutical and medical device cases does not violate the First Amendment. At ...

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Stericycle DPA signals more aggressive use of independent compliance monitors

On April 20, 2022, the U.S. Department of Justice (DOJ) announced it had entered a three-year deferred prosecution agreement (DPA) with Stericycle Inc. to resolve allegations that it...

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Stericycle DPA signals more aggressive use of independent compliance monitors

On April 20, 2022, the U.S. Department of Justice (DOJ) announced it had entered a three-year deferred prosecution agreement (DPA) with Stericycle Inc. to resolve allegations that it...

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Building a resilient tech strategy: Cyber attacks

Being an innovative business comes with its challenges and legal risks. In recent years, there has been a major increase in cyber attacks, and this is a real risk for every business. ...

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A closer look: Remote monitoring terms in Clinical Trial Agreements require careful review

Sponsors of clinical trials in the United States have a regulatory responsibility under 21 CFR Part 312.50 to monitor the progress of clinical studies. Historically, Sponsors performed...

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FDA issues ambitious new draft guidance to promote clinical trial diversity

On April 14, the U.S. Food and Drug Administration (FDA) released a new draft guidance to industry for increasing racial and ethnic diversity in clinical trials. The draft...

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