Time to Comment on the NEW FDA Guidelines for Social Media Use in Healthcare

Draft Guidance for Industry on Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices; Availability: https://www.federalregister.gov/articles/2014/06/18/2014-14221/draft-guidance-for-industry-on-internetsocial-media-platforms-correcting-independent-third-party The FDA has released new guidelines for how social media is used in healthcare. The University of Michigan had been involved in commenting on the original call for comments on this topic, and emphasized the …

#FDA vs #23andMe, Take Two — Hashtags of the Week (HOTW): (Week of December 9, 2013)

Last week we tracked opinions and responses with regards to the FDA warning letter sent to the direct-to-consumer personal genomics service, 23andMe. This week 23andMe officially announced that they are reducing the services they offer in response to the FDA's warning letter. So what has been the reaction on Twitter? Let's take a look at …

FDA and New Food Safety Rules

With a law that President Obama signed 2011, the Food and Drug Administration (FDA) will propose 5 new ruls to strengthen the nation's food safety system. According to the FDA's website: "The first two have been proposed and published for public comment: Preventive Controls for Human Food: This rule sets safety requirements for facilities that …

Food and Drug Administration (FDA) Substance Registration System (SRS) added to PubMed records

From the National Library of Medicine: Unique Ingredient Identifiers (UNIIs) are being introduced into the Medical Subject Headings (MeSH) vocabulary starting with the 2013 MeSH Supplementary Concept Records (SCRs). The UNIIs are an integral part of the FDA Substance Registration System. They appear in several databases such as the Veterans Administration National Drug File Reference …

FDA Approves First Medication to Reduce HIV Risk

Reposted from the FDA Consumer Updates: FDA Approves First Medication to Reduce HIV Risk People diagnosed with HIV—the human immunodeficiency virus that without treatment develops into AIDS—take antiviral medications to control the infection that attacks their immune system. Now, for the first time, adults who do not have HIV but are at risk of becoming …

100K Genome Project

The Food and Drug Administration has launched the 100K Genome Project whose goal is to create a public gene sequences database of the 100,000 bacteria that have been responsible for outbreaks of foodborne illnesses around the world.  In partnership with the University of California Davis and Agilent Technologies, the FDA hopes this database will: "enable …

Groups urge action on food safety law

From the New York Times: Ten consumer groups that helped promote a landmark food safety law passed in 2010 say the Obama administration is holding up the rules that would put it into effect, a delay they say could cost money and lives this summer, the peak season for food contamination outbreaks. The Food Safety …

Health-care apps for smartphones pit FDA against tech industry

From the Washington Post: Three tries. More than two years. And roughly $150,000. That’s what it took for MIM Software to get the Food and Drug Administration’s clearance for a smartphone application that physicians can use to view MRIs and other medical images.Three tries. More than two years. And roughly $150,000. “It was 2008 when …