FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: PROCESS FOR FDA DATA REQUESTS TO INFORM CERTAIN OVER-THE-COUNTER MONOGRAPH DRUG ACTIVITIES; PROCEDURE

WASHINGTON, July 16 -- Food and Drug Administration has issued a notice called: Process for FDA Data Requests To Inform Certain Over-the-Counter Monograph Drug Activities; Procedure.

The notice was published in the Federal Register on July 16 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.

Summary: The Food and Drug Administration (FDA or Agency) is announcing the process for FDA to issue Data Requests for the submission of data from the public to help inform certain future over-the counter (OTC) monograph drug activities, including development of FDA-initiated proposed orders to modify conditions described in an OTC monograph. FDA is issuing this notice to inform the public and interested parti...