by Lengea Law | Dec 19, 2024 | News
On December 19, 2024, the U.S. Food and Drug Administration (FDA) made a critical ruling that has major legal and regulatory consequences for the healthcare sector. The FDA declared that the shortage of tirzepatide, the active ingredient in Eli Lilly’s weight loss...
by Lengea Law | Nov 21, 2024 | News
The U.S. District Court for the Northern District of Texas recently released a joint status report in the case Outsourcing Facilities Association v. U.S. Food and Drug Administration (Case No. 4:24-cv-00953-P). This report, filed on November 21, 2024, outlines ongoing...
by Lengea Law | Nov 15, 2024 | News
The FDA’s recent decision to remove tirzepatide from its shortage list has triggered a legal battle with significant implications for medical spas and compounders. In response to a lawsuit filed by the Outsourcing Facilities Association (OFA) and North American Custom...
by Lengea Law | Nov 4, 2024 | News
The recent case involving Rebecca Fadanelli, owner of Skin Beaute Med Spa, who was arrested on November 1, 2024, on charges of illegal medical practices, is a stark reminder of the importance of integrity and compliance within the med spa industry. While this...
by Lengea Law | Oct 12, 2024 | News
In a surprising turn of events, the U.S. Food and Drug Administration (FDA) has agreed to reconsider its decision to remove tirzepatide, the active ingredient in Eli Lilly’s diabetes therapy Mounjaro and weight loss therapy Zepbound, from its drug shortage list. This...
by Lengea Law | Oct 10, 2024 | News
The pharmaceutical landscape is once again at the center of a legal battle. This time, the battle involves the popular drug tirzepatide, manufactured by Eli Lilly under the brand name Mounjaro. Compounders, the small but crucial segment of the pharmaceutical world,...