FDA 'Evolving' Homeopathic Drug Enforcement With Risk-Based Approach

Problems stated in a draft guidance where FDA will "prioritize enforcement and regulatory actions" includes products with routes of administration other than oral and topical or intended to be used for the prevention or treatment of serious or life-threatening diseases and conditions.

FDA will put more teeth into its homeopathic drug industry oversight under a draft guidance that identifies problems it will target for enforcement while allowing the products to remain available without pre-market approval.

The draft guidance published Dec. 18 states that FDA will use an enforcement approach similar to its oversight...