FDA: Complaints About Homeopathic Remedies Spur Review
The agency heard from supporters and critics of products like Zicam Allergy Relief and Cold-Eeze at a two-day hearing. Meanwhile, it issued guidance on how device makers should handle data from overseas clinical trials.
The Associated Press:
FDA: Safety Problems Prompted Review Of Homeopathic Remedies
A top federal drug regulator says that increased safety problems with homeopathic remedies contributed to the government's decision to revisit its oversight of the products at a public hearing this week. The Food and Drug Administration on Tuesday wrapped up a two-day meeting to hear from supporters and critics of products like Zicam Allergy Relief and Cold-Eeze, alternative remedies that are protected by federal law, but not accepted by mainstream medicine. (Perrone, 4/21)
FDA Issues Guidance On Data, Promotional Materials
The Food and Drug Administration issued two draft guidance documents Tuesday outlining how medical device companies should handle data from overseas clinical trials and how drug makers should submit promotional materials for prescription drugs and biologics. The guidance on medical devices follows on a provision in the Food and Drug Administration Safety and Innovation Act codifying the agency’s long-standing policy of accepting data from clinical trials conducted outside the US, as long as the manufacturer proves the data meet the agency’s standards. (Gustin, 4/21)