2013: A Big Year for Genomics, Genetic Testing and...

2013 was a banner year for raising the visibility of genetic testing. The news varied. It can be argued, however, that all parties (patients, clinicians, industry and researchers) have benefited from the increased coverage. This brief snapshot of the stories about genetic testing that made it into the headlines in 2013 suggests that we are at a critical point. Patient demand, industry innovation and policies are converging. Consumers seem to embrace the technology and the opportunity to take action with the information they may receive. The law is carefully considering how to treat genetic information and the regulatory agencies continue to...

FDA Social Media Guidance Removes Some Barriers

This week, the FDA issued draft social media guidance specifically focused on requirements, responsibility and process for postmarketing submission for approved drugs and biologics. While the long official title is “Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics” the document covers two primary areas: Considerations to determine when interactive media (Facebook, Twitter, blogs, forums, etc.) are subject to the FDA’s postmarketing submission requirements How firms can maintain regulatory compliance given the unique features...