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Audit.pdf

690914.pdf

🔗 Source: gao.gov

📊 Size: 323 KB

👤 Author: U.S. Government Accountability Office, http://www.gao.gov

⬇️ Downloads: 149

Summary

The Food and Drug Administration (FDA) approved changes to the labeling of Mifeprex, a prescription drug used for medical termination of early pregnancy, in 2016. The changes included a revised dosing regimen, increased gestational age limit, and omission of the requirement for a second visit with a healthcare provider. FDA based its approval on peer-reviewed studies and adverse event data, and determined that the rates of certain adverse events remained stable and acceptably low. FDA has conducted monitoring activities, including inspections and review of adverse event reports, which have not identified significant safety concerns. Stakeholder organizations have mixed views on FDA's monitoring and the safety of Mifeprex, with some expressing concerns about underreporting of adverse events and safety issues related to the revised labeling.

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Description

The Food and Drug Administration (FDA) approved changes to the labeling of Mifeprex, a prescription drug used for medical termination of early pregnancy, in...

Technical Information

File Format: PDF
File Size: 323 KB
Pages: 34
Language: EN
Author: U.S. Government Accountability Office, http://www.gao.gov
Total Downloads: 149
Last Updated: 1 week ago

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This PDF document about audit provides comprehensive information and guidance. Whether you're a beginner or advanced user, this resource offers valuable insights into audit.