Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for Industry on Adverse Event Reporting for Outsourcing Facilities

الملخص

The Food and Drug Administration (FDA) is announcing that a collection of information entitled "Guidance for Industry on Adverse Event Reporting for Outsourcing Facilities Under Section 503B of the Federal Food, Drug and Cosmetic Act" has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.