Department of Health and Human Services October 15, 2007 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Antibacterial Drug Products: Use of Noninferiority Studies to Support Approval.'' The purpose of this guidance is to inform industry of FDA's current thinking regarding appropriate clinical study designs to evaluate antibacterial drugs, and to ask sponsors to amend ongoing or completed studies accordingly. This guidance is in response to a number of public discussions in recent years regarding the use of active-controlled studies designed to show noninferiority as a basis for approval of antibacterial drug products.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed Without an Approved Application.'' This draft guidance document provides guidance to industry on postmarketing serious adverse event reporting for nonprescription (over-the-counter (OTC)) human drugs marketed without an approved application. It gives guidance on the minimum data elements that should be included in a serious adverse event report, the label that should be included with the report, reporting formats for paper and electronic submissions, and how and where to submit the reports. Separate guidance, issued by the Center for Food Safety and Applied Nutrition on reporting for dietary supplements, is announced elsewhere in this issue of the Federal Register.

In accordance with section 10(a) of the Federal Advisory Committee Act, this notice announces a meeting of the National Advisory Council for Healthcare Research and Quality.