23andMe and the FDA: what really drove them apart

What Really Drove 23andMe And The FDA Apart
BY ROBERT SAFIAN, fastcompany.com

Is getting a $99 DNA test really hazardous to your health? Our editor-in-chief decodes an innovation dustup.

When we put 23andMe CEO Anne Woj­ci­c­ki on the cover of Fast Com­pa­ny’s Novem­ber issue, we didn’t expect the FDA to yank the com­pa­n…


FDA reigning in medical apps

FDA to start reining in the Wild West of medical apps
by Elizabeth Armstrong Moore, cnet.com

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.

The Wild West of mobile med­ical apps is get­t…


The American Society of Pharmacognosy


English: Logo of the U.S. Food and Drug Admini...
English: Logo of the U.S. Food and Drug Administration (2006) (Photo credit: Wikipedia)


News & Announcements

Jan­u­ary 3rd, 2013

“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…


The American Society of Pharmacognosy

FDA finally tries to regulate pharma social media, God Help Them

FDA Guidance on Responding to Unsolicited Requests for Off-Label Information

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…

RT @pharmaguy: FDA Guidance on Responding to Unsolicited Requests for Off-Label Information. Free PMN article: http://flip.it/IukwS http://flip.it/GpdGc

Fda (Photo credit: Wikipedia)

To improve drug safety, FDA should check its mixed-up files

English: Logo of the U.S. Food and Drug Admini...
English: Logo of the U.S. Food and Drug Administration (2006) (Photo credit: Wikipedia)

This is really kind of sad…To improve drug safety, FDA should check its mixed-up files – The Boston Globe.

FDA final rule on safety info, but still no word on social media

Fda (Photo credit: Wikipedia)

FDA issues final rule on safety information during clinical trials

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.