FDA Related Insights & Resources

FDA Warning Letter vs. FDA Form 483: The Difference Can Decide What Happens Next One of the most common questions companies ask after an FDA inspection is this: What is the difference between a Form FDA 483 and an FDA warning letter? The short answer is that a 483 is generally...

 FDA Authority vs. Medical Practice Executive Summary: In drafting this article, I find that FDA authority over peptides centers on their status as drugs/biologics – the FDA regulates their manufacturing, importation, and distribution, but not the practice of medicine (i.e. a physician’s decision to prescribe or administer). As FDA guidance...

Criminal Prosecution Under the Federal Food, Drug, and Cosmetic Act (FDCA) Federal criminal prosecutions for FDA adulteration and misbranding charges have become one of the most aggressive—and least understood—frontiers of modern white-collar enforcement. Conduct that was once addressed through inspections, warning letters, or civil remedies is now increasingly charged as...