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...

In the News

This Week’s Headlines Bionic Vision Secures Funding for “Bionic Eye” Development Posted 4/5/2017 Bionic Vision has announced plans to move forward with development and commercialization of an implant which would enable partial treatment of retinitis pigmentosa,...