Tag: FDA

23andMe and the FDA: what really drove them apart

by timbatchelder, posted in Data Governance, Health Informatics, Knowledge Management

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… http://flip.it/UoyAS Related … Continue reading 23andMe and the FDA: what really drove them apart

FDA reigning in medical apps

by timbatchelder, posted in Data Governance, Health Informatics, Knowledge Management, Network Science

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 … Continue reading FDA reigning in medical apps

The American Society of Pharmacognosy

by timbatchelder, posted in Digital health, Health Informatics, Knowledge Management

  pharmacognosy.us 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… http://flip.it/CYKFs The American Society of Pharmacognosy Related articles Salix Wins FDA Approval of Dragon's Blood Drug for Diarrhea … Continue reading The American Society of Pharmacognosy

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

by timbatchelder, posted in Data Governance, Health Informatics, Knowledge Management, Regenerative Economy, Security & Privacy

FDA Guidance on Responding to Unsolicited Requests for Off-Label Information pharma-mkting.com 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 … Continue reading FDA finally tries to regulate pharma social media, God Help Them

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

by timbatchelder, posted in Data Governance, Health Informatics, Linguistic Search, Security & Privacy

This is really kind of sad...To improve drug safety, FDA should check its mixed-up files - The Boston Globe. Related articles FDA Issues New Cautionary Guidelines for Metal-on-Metal Hip Implants, Parker Waichman LLP Reports (prweb.com) DrugRisk Announces Updated Information on Mirena Lawsuits (prweb.com) FDA's Hazard Analysis and Risk-Based Preventive Controls for Human Food and Current … Continue reading To improve drug safety, FDA should check its mixed-up files

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

by timbatchelder, posted in Health Informatics, Knowledge Management, Linguistic Search, Regenerative Economy

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