Drug Products Labeled as Homeopathic; Draft Guidance for Food and Drug Administration Staff and Industry; Availability

Streszczenie

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for FDA staff and industry entitled "Drug Products Labeled as Homeopathic." This draft guidance describes how FDA intends to prioritize enforcement and regulatory action with regard to drug products, including biological products, labeled as homeopathic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.