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FDA Warning Letters Regulatory Violations

Fuerst Ittleman David & Joseph

FDA Issues Five Warning Letters to Makers of Knockoff GLP-1 Drugs

On December 17, 2024, the FDA published five (5) warning letters previously issued to makers of knockoff GLP-1 drugs. Four of the five warning letters were to companies (specifically, Xcel Research, Prime Vitality, Summit...more

Gardner Law

FDA Issues Numerous Warning Letters

Gardner Law on

The U.S. Food and Drug Administration (FDA) uses warning letters to notify manufacturers that they have violated the FDA’s regulations or federal law. Manufacturers that receive warning letters must respond promptly, and they...more

Hogan Lovells

In midst of COVID-19, FDA reminds industry that it plays both good and bad cop

Hogan Lovells on

U.S. authorities are actively policing entities making illegal promotional claims that products mitigate, prevent, treat, cure, or diagnose COVID-19....more

Hogan Lovells

The Crackdown Continues:  FDA Takes Action Against Company And Its Autologous Stem Cell Product, Alleging Significant Safety...

Hogan Lovells on

Last week, FDA published a January 3, 2018 Warning Letter issued to American CryoStem for marketing Atcell—an adipose tissue derived stem cell product—without FDA approval and for several drug current Good Manufacturing...more

Farrell Fritz, P.C.

FDA Issues Warning Letters To Cannabidiol Product Manufacturers Over Health Claims

Farrell Fritz, P.C. on

On November 1, 2017, the Food and Drug Administration (FDA) published a release concerning its issuance of warning letters to four companies concerning the marketing of products containing cannabidiol (CBD)....more

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