Draft Guidance for Industry on Labeling Over-the-Counter Human Drug Products; Updating Labeling in ANDA's; Availability

Zusammenfassung

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Labeling Over- the-Counter Human Drug Products; Updating Labeling in ANDA's." This draft guidance is intended to assist manufacturers, packers, and distributors of over-the-counter (OTC) drug products marketed under abbreviated new drug applications (ANDA's) and manufacturers of reference listed drugs (RLD's) to implement the agency's regulation on standardized content and format requirements for the labeling of OTC drug products.