Home > Newsletters > FDAnews Device Daily Bulletin > FDA Regulatory Affairs Office Restructured to Respond to Growing Industry Globalization
FDAnews Device Daily Bulletin
Sept. 25, 2012 | Vol. 9 No. 188
FDA Regulatory Affairs Office Restructured to Respond to Growing Industry Globalization
The FDA is planning to reorganize its Office of Regulatory Affairs (ORA), including creating new offices and reorganizing others, as it takes steps to dissolve cumbersome domestic and international distinctions and keep pace with increasingly global operations. The restructuring will also better position ORA to address new legislative authorities included in the FDA Safety and Innovation Act (FDASIA), signed into law this summer, which boosts supply chain oversight and inspection authority while allowing for risk-based approaches to both — major changes that call for “new strategies” and enhanced coordination across the office, according to an agency fact sheet on the ORA reorganization.
Devices & Diagnostics Letter
ePublishing :: CMS, Hosting & Web Development | © Copyright by FDAnewsAll rights reserved. Do not duplicate or redistribute in any form.