The FDA says it is only regulating products that turn smartphones into medical devices it already oversees, such as apps that let your phone act as an electronic stethoscope or give feedback on CPR.
“On New Year’s Eve of 2012, the US Food and Drug Administration (FDA) announced its approval of crofelemer (Fulyzaq™, Salix Pharmaceuticals, Ltd., Raleigh, North Carolina) — marking the sec…
Two days after Christmas, on December 27, 2011, while most of us were still on vacation, the FDA quietly issued “Guidance for Industry Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical…
This is an interesting announcement and reveals to me the fact that the FDA is coming to grips with the fact that the current process for reporting adverse events needs an overhaul including refining what qualifies as an AE and how they are reported. I believe the landscape for AE reporting is about to change dramatically owing to another trend which is quite outside the FDA’s control, namely social media. A number of articles show that due to the growth of online medical communities and web 2.0 means of sharing science and medical knowledge, the idea of capturing AEs via phone call or other report to a drug company from an HCP is becoming increasingly obsolete. Reportable adverse events are far less common than most people suspect. As of 2009 there were only approximately 166 reportable adverse events per day recorded across the entire pharma industry. Increasingly pharma companies are examining how (and to what extent) they will be required to capture and monitor AEs in online discussions occurring on their brands. The amount of content to monitor is potentially staggering and yet algorithms are being developed that will automate this to some extent. This has the potential to be much more useful than simply tracking isolated AE incidents for the FDA since it will allow both regulators and industry to gain much more sophisticated intelligence on the experience of mass numbers of customers with the products.
Science, Technology, Society 