Process for FDA Data Requests To Inform Certain Over-the-Counter Monograph Drug Activities; Procedure

Official abstract: 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 parties of the process that FDA is implementing to issue these Data Requests.