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Cozen O'Connor

The State AG Report – 06.26.2025

Cozen O'Connor on

Here are curated AG and federal regulatory news stories highlighting key areas in which state and federal regulators’ decisions are having an impact across the US: • All AGs Settle with Purdue Pharma over Opioid-Related...more

Arnall Golden Gregory LLP

It's the Little Things: FDA Issues a Warning Letter for Improper Drug Listing

Arnall Golden Gregory LLP on

In a nod to Alice Cooper’s 2000 song, “It’s the Little Things” (or, for literary fans, Robert Frost’s quote, “It’s the little details that are vital; little things make big things bigger”), the Food and Drug Administration’s...more

Bradley Arant Boult Cummings LLP

The Government’s Watchful Eye on Fraud Stemming from Stem Cell Therapy

Bradley Arant Boult Cummings LLP on

Stem cell therapy, also known as regenerative medicine, has been around for decades, but in recent years, the use of and interest in stem cell therapy has increased exponentially. The dramatic utilization of stem cell...more

Cadwalader, Wickersham & Taft LLP

The Delaware Court of Chancery Rejects Termination of Merger Agreement Based on Material Adverse Effect

Cadwalader, Wickersham & Taft LLP on

In Channel Medsystems, Inc. v. Boston Scientific Corporation, the Delaware Court of Chancery rejected an attempt by Boston Scientific to terminate and thus avoid consummating a merger agreement with Channel on the grounds...more

Mintz - Health Care Viewpoints

The Other Shoe Drops: FDA Withdraws 30-Year-Old Homeopathic Drug Enforcement Policy and Puts Industry on Notice of Further...

Mintz - Health Care Viewpoints on

To anyone who has been following government enforcement and private litigation trends related to the over-the-counter (OTC) homeopathic drug industry over the past several years, the Food and Drug Administration’s (FDA)...more

Hogan Lovells

FDA resumes enforcement relating to laboratory developed tests

Hogan Lovells on

On April 4, 2019, the U.S. Food and Drug Administration's (FDA or the agency) Office of In Vitro Diagnostics and Radiological Health issued a Warning Letter to Inova Genomics Laboratory in one of the first FDA enforcement...more

Hogan Lovells

FDA Shows that it Means Business in Stopping Stem Cell Clinics that Put Patients at Risk

Hogan Lovells on

On Wednesday, FDA announced that it filed two complaints in federal court seeking injunctions to stop marketing efforts of unapproved stem cell treatments by US Stem Cell Clinic of Sunrise, Florida, and California Stem Cell...more

Shook, Hardy & Bacon L.L.P.

Dietary Supplement & Cosmetics Legal Bulletin | April 2018

Shook, Hardy & Bacon L.L.P. on

FDA Issues Guidance on Concentrated Caffeine - The U.S. Food and Drug Administration (FDA) has released guidance clarifying that "dietary supplements containing pure or highly concentrated caffeine in powder or liquid...more

Orrick, Herrington & Sutcliffe LLP

Where White Collar Enforcement Is Heading

Orrick, Herrington & Sutcliffe LLP on

Orrick partners Greg Morvillo and Amy Walsh co-authored an article for Law360 that examines how certain significant developments in various industries, coupled with official statements by the U.S. Securities and Exchange...more

Troutman Pepper Locke

Accepting Anonymous Tips: FDA's Website for Reporting Medical Device Regulatory Misconduct

Troutman Pepper Locke on

For device manufacturers and sellers, the website represents another source of information to monitor for possible challenges ahead. Unidentified tipsters — from disgruntled former employees to plaintiffs’ attorneys —...more

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