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Manufacturers › Informed Consent › Pharmaceutical Industry

Stark & Stark

What to Know About the Latest Updates in Ozempic and Wegovy Lawsuits

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Key takeaways: The legal claims against Novo Nordisk are not about banning the drug. They are about accountability and informed consent. The core of these lawsuits is the product liability principle known as “failure to...more

Knobbe Martens

FDA Issues Updated Informed Consent Guidance for Clinical Investigations

Knobbe Martens on

On August 15, 2023, the Food and Drug Administration (FDA) issued its updated guidance on informed consent for clinical investigations. The FDA’s updated guidance is titled Informed Consent Guidance for IRBs, Clinical...more

Verrill

"Right to Try" Comes to the Federal Stage: What Stakeholders Should Do Now

Verrill on

On May 30, 2018, surrounded by patients directly impacted by tragic and intractable diseases, President Trump signed into law the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017...more

Foley Hoag LLP

Federal Court Holds Manufacturer of Investigational Drug and Medical Device Responsible for Clinical Trial Investigator’s...

Foley Hoag LLP on

In a recent decision subject to multiple flaws, the United States District Court for the District of Massachusetts refused to dismiss a suit against the manufacturer of an investigational drug and medical device used in a...more

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