^®: CRE Regulatory Action of the Week

FDA Seeks Comment on Draft Homeopathic Drug Guidance
The U.S. Food and Drug Administration has published draft guidance for FDA staff and industry entitled "Drug Products Labeled as Homeopathic." This draft guidance describes how FDA intends to prioritize enforcement and regulatory action with regard to drug products, including biological products, labeled as homeopathic and marketed in the United States without the required FDA approval. Comments received within 90 days after Federal Register publication of this announcement will be considered by FDA in producing the final version of this draft guidance. Publication is currently scheduled for December 20, 2017. Once it is published, a copy of the draft guidance will be available at www.regulations.gov, Docket No. FDA-2017-D-6580. The published Federal Register notice, which will contain more details and relevant links, will be available in this Docket. It is also available here: https://www.federalregister.gov/documents/2017/12/20/2017-27157/guidance-drug-products-labeled-as-homeopathic