date:Dec 03, 2012
ed in these assessments and worked closely with FDA in identifying vulnerabilities and developing mitigation strategies.
FDA and its contractor will incorporate the suggested changes into a second prototype, which will be reviewed later this year. The software should be available in the spring of 2013. IDFA is continuing to work closely with FDA on this tool and will help member companies use it when it is finalized.
In addition to the tool, FDA will issue an Advanced Notice of Proposed Rul