Over-the-Counter Marketing of Internal Analgesic, Antipyretic, and Antirheumatic Drug Products; Background Document for Advisory Committee Meeting; Availability; Establishment of a Public Docket and Request for Comments

Samenvatting

The Food and Drug Administration is announcing the availability of a background document for the joint meeting of the Nonprescription Drugs Advisory Committee and the Arthritis Advisory Committee on effectiveness data requirements and labeling for over-the- counter (OTC) marketing of internal analgesic, antipyretic and antirheumatic drug products scheduled for September 8 and 9, 1994. The background information is being made available to ensure that all interested parties are aware of the issues that are the subject of the committee discussion. FDA is also announcing that it is establishing a public docket for comments, views, and other information submitted to the agency on these subjects from interested persons.