Homeopathic Regulatory Evaluation Stocked With FDA Concerns, Industry Answers
This article was originally published in The Tan Sheet
Executive Summary
The industry wants FDA to consider that a fraction of poison control reports are for homeopathics compared to other drugs and the agency’s current enforcement authorities maintain compliance in manufacturing and marketing the products. FDA is considering whether to maintain its policy that recognizes an ingredient’s inclusion in the HPUS monograph as pre-market approval.