Two announcements made by FDA in late October signal a marked change to FDA’s regulatory approach to “homeopathic” drugs. On October 25, 2019, FDA withdrew the 1988 Compliance Policy Guide (“CPG”) 400.400 Conditions Under Which Homeopathic Drugs May Be Marketed, and, concurrently, published revised draft guidance titled Drug Products Labeled as Homeopathic (the “Revised Homeopathic Draft Guidance”).
Homeopathy—an alternative medical approach that began in the late 18th century—is based on the belief that (1) a substance that causes symptoms in a healthy ...
Blog Editors
Recent Updates
- First Circuit Clarifies When Clinical Labs Can Rely on Physician Orders
- Understanding the False Claims Act Statute of Limitations—and the Debate Over the “Last Overt Act” Rule
- Podcast: The Down-Low on Data for Value-Based Enterprises and Their Participating Providers – Diagnosing Health Care
- Second Circuit Affirms Denial of Preliminary Injunction in Challenge To N.Y. Law Restricting Weight Loss and Muscle Building Supplement Sales to Minors
- The DOJ’s Bulk Sensitive Data Rule and Your Obligation to “Know Your Data”