In the News

This Week’s Headlines Medical Device Industry Expecting an Increase in Hacking in 2017 Posted 4/12/2017 The medical device industry is preparing itself for an expected wave of device hacks in 2017. The projection is based on numerous high-profile attacks within...

New Age Regulatory Operations

How the eCTD has Changed Submission Teams In May of this year, regulatory operations leaders will finally begin preparing therapy submissions under one standardized format. The eCTD’s compliance deadlines will force organizations to move completely beyond clerical...

In the News

FDA Genetics Testing Approval 23andMe Secures FDA Approval for Direct to Consumer Disease Risk Assessment 23andMe has secured FDA approval to begin commercialization of Personal Genome Service Genetic Health Risk tests for ten disease conditions. The test will be...