Health IT Analytics: FDA Makes Real-World Data Available on Google Cloud Platform. “The FDA’s MyStudies platform, a tool that aims to collect real-world data to improve clinical trials and advance medical research, is now available on Google Cloud Platform. Launched in November 2018, the MyStudies open-source technology platform supports drug, biologic, and device organizations as they collect and report real-world data for regulatory submissions.”
FDA
Science: FDA and NIH let clinical trial sponsors keep results secret and break the law
Science: FDA and NIH let clinical trial sponsors keep results secret and break the law. “Science examined more than 4700 trials whose results should have been posted on the NIH website ClinicalTrials.gov under the 2017 rule. Reporting rates by most large pharmaceutical companies and some universities have improved sharply, but performance by many other trial sponsors—including, ironically, NIH itself—was lackluster. Those sponsors, typically either the institution conducting a trial or its funder, must deposit results and other data within 1 year of completing a trial. But of 184 sponsor organizations with at least five trials due as of 25 September 2019, 30 companies, universities, or medical centers never met a single deadline.”
MobiHealthNews: FDA, NIH’s newest app asks clinicians to log case data when treating difficult infections
MobiHealthNews: FDA, NIH’s newest app asks clinicians to log case data when treating difficult infections. “The FDA and National Institutes of Health are tapping the clinical community and a newly launched mobile platform in its search for novel infectious disease interventions. Called CURE ID, the online data repository will allow clinicians to report instances in which existing FDA-approved drugs are used to successfully treat infections.”
Health IT Analytics: NIH, FDA Launch Database for Parkinson’s Disease Precision Medicine
Health IT Analytics: NIH, FDA Launch Database for Parkinson’s Disease Precision Medicine. “The Accelerating Medicines Partnership (AMP) program for Parkinson’s disease (PD) has launched a data portal to help researchers develop precision medicine therapies for the condition. The portal includes de-identified data collected from 4,298 patients with Parkinson’s and will enable researchers to study complex data sets and perform genome-wide analyses.”
WTVD: FDA forces some social media influencers to add warnings to posts after they advertise unsafe vape, e-liquid products
WTVD: FDA forces some social media influencers to add warnings to posts after they advertise unsafe vape, e-liquid products. “Some popular social media accounts are posting new warnings after a federal crackdown. The Federal Trade Commission and the Food and Drug Administration are targeting accounts that promote and market vape and e-liquid products.”
StarTribune: FDA releases millions of records of incidents involving medical devices
StarTribune: FDA releases millions of records of incidents involving medical devices. “The U.S. Food and Drug Administration on Friday published millions of previously undisclosed reports of problems and post-surgical complications involving medical devices, including reports on implantable cardiac defibrillators, pacemaker electrodes and dental implants.”
Engadget: Social media ads for vaping must include nicotine warnings, FTC says
Engadget: Social media ads for vaping must include nicotine warnings, FTC says. “The Federal Trade Commission (FTC) and US Food and Drug Administration (FDA) warned a handful of ‘e-liquid,’ or vape, companies that they — and their social media influencers — must follow the same advertising rules as everyone else. Specifically, ads for vaping products that contain nicotine must include warning labels, as nicotine is an addictive chemical. “
