Regulatory Focus: FDA Launches Searchable Purple Book

Regulatory Focus: FDA Launches Searchable Purple Book. “The US Food and Drug Administration (FDA) on Monday unveiled the first version of its searchable online database of biological product information, known as the Purple Book. Building off the previous PDF lists of biological products, the database now allows for easier searches and includes information on product names (proprietary and proper), the type of biologics license application (BLA) that was submitted, strength of the biologic, dosage form, product presentation, license status, BLA number and approval date.” I didn’t know how a “biological product” was defined. I got educated via this FDA PDF.

Ars Technica: Why is the healthcare industry still so bad at cybersecurity?

Ars Technica: Why is the healthcare industry still so bad at cybersecurity?. “Many articles about cybersecurity risks in healthcare begin with descriptions of live simulations (so when in Rome). Imagine a doctor completely unaware of what they’re walking into triaging two patients: one in need of a hospital cardiac catheterization lab after an irregular electrocardiogram (EKG) reading, the other suffering from a stroke and needing a CT scan. All systems are down due to ransomware, so the physician working through the scenario can’t access electronic health records or use any of the assessment methods modern medicine is so reliant on. So, what to do?” Incredibly deep dive. If you’re at all interested in security issues around health care, I urge you to read this article.

Tubefilter: The FDA Is Studying Influencers Who Endorse Healthcare Products

Tubefilter: The FDA Is Studying Influencers Who Endorse Healthcare Products. “The Food and Drug Administration (FDA) is probing the world of influencers who endorse healthcare products. In a proposal published Jan. 28, the agency said it’s already conducted two related studies. One concluded that more people buy drugs and products endorsed by physicians, pharmacists, and other consumers than drugs endorsed by celebrities. The other found that consumers think expert endorsers are more credible than celebrities, but pay the same amount of attention to ads from both.”

Health IT Analytics: FDA Makes Real-World Data Available on Google Cloud Platform

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.”

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.”