Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for Industry on Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed Without an Approved Application

Streszczenie

The Food and Drug Administration (FDA) is announcing that a collection of information entitled "Guidance for Industry on Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed Without an Approved Application" has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.