The Food and Drug Administration (FDA or the Agency) is announcing the availability of a draft guidance for industry entitled ``Adverse Event Reporting for Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act.'' Under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), an outsourcing facility must submit adverse event reports to FDA. This guidance explains FDA's current thinking on adverse event reporting for outsourcing facilities.
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Adverse Event Reporting for Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or the Agency) is announcing the availability of a draft guidance for industry entitled ``Adverse Event Reporting for Outsourcing Facilitie...
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80 FR 8872
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“Adverse Event Reporting for Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry; Availability,” thefederalregister.org (February 19, 2015), https://thefederalregister.org/documents/2015-03419/adverse-event-reporting-for-outsourcing-facilities-under-section-503b-of-the-federal-food-drug-and-cosmetic-act-draft-gu.