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Warning Letters Prescription Drugs Healthcare

Sheppard Mullin Richter & Hampton LLP

What to Watch: Potential Increase in Enforcement of “RUO” Diagnostics

Last spring, we wrote about a warning letter the United States Food & Drug Administration (“FDA” or the “Agency”) issued to Agena Bioscience Inc. (the “Agena Warning Letter”) for allegedly promoting its diagnostic product...more

Wiley Rein LLP

FTC Sends Warning Letters to 37 Eyeglass and Contact Lens Prescribers Over Possible Rule Violations

Wiley Rein LLP on

On June 3, 2025, the Federal Trade Commission (FTC) announced its staff had sent warning letters to 37 contact lens prescribers that, according to the FTC, were the subject of consumer complaints concerning possible...more

Arnall Golden Gregory LLP

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

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

King & Spalding

FDA Releases Warning Letters to Providers Concerning Clinical Trial Supervision

King & Spalding on

The FDA recently released three warning letters that it previously issued to two health care providers relating to prescription drug and medical device clinical trials. The letters, sent in late 2013 and early 2014, detail...more

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