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Guide (“CPG”) 400.400 Conditions Under Which Homeopathic Drugs May Be Marketed, and, concurrently, published revised draft guidance titled Drug Products Labeled as Homeopathic (the “Revised Homeopathic Draft Guidance”).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
- Telehealth Cliff Averted, for Now (but September Is Six Months Away)
- The End of the Self-Affirmed GRAS Pathway?
- DEA Telemedicine Rules Further Delayed Until (Nearly) 2026
- Gender-Affirming Care Protections Eroded by Recent HHS Guidance and White House Executive Orders
- Important Negotiating Points in Commercial Real Estate Purchase and Sale Contracts Negotiating the Letter of Intent