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Southern District of Florida Levels Injunction Against Stem Cell Clinic on Behalf of FDA

On June 25, 2019, the Southern District of Florida issued an injunction on behalf of the Food and Drug Administration (FDA) preventing US Stem Cell Clinic LLC (USSCC) and its parent company US Stem Cell Inc. from manufacturing and distributing certain stem cell treatments. As the FDA increases its oversight and enforcement of stem cell treatments, this decision appears to affirm the agency's position that certain stem cell products should...

FDA Issues New Warning Letters to API Repackers

The Food and Drug Administration (FDA) recently issued warning letters to three repackers of Active Pharmaceutical Ingredients (API) for alleged violations of Current Good Manufacturing Practice (CGMP) requirements. The FDA's issuance of these warning letters, along with statements made in a press release dated July 2, 2019, indicate that the FDA is increasing its oversight of the global supply chain for pharmaceuticals and active pharmaceutical ingredients, and issuing warning letters...