Food and Drug Administration (FDA)
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FCC To Hire Healthcare Director, Step Up Health Efforts
The Federal Communications Commission (FCC) held a public briefing this week with its mHealth Task Force, which formed just this past June to work with various other healthcare professionals and technologists to create a report full of “concrete” next steps that the FCC (and other agencies) can take to facilitate the adoption and acceleration of mHealth in the United States. Read More »
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FDA and Patient-Focused Drug Development
The patient perspective is an important part of the drug development process. Through social media, the Internet, and advocacy groups, patients have become more informed about how drugs and devices are developed. FDA is committed to using this information to help foster the development and availability of safe and effective drugs that meet the needs of the American public. Read More »
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FDA Antimicrobial Resistance Guidelines Fail to Address Root Causes
Last December, the Food and Drug Administration (FDA) published two controversial documents on its website: Guidance 213 and the Veterinary Feed Directive (VFD). The guidelines stirred a firestorm of protests from public health offiicials who argue that the guidelines are too weak to prevent the continuing growth of antibiotic resistant germs...the crisis, as outlined by Dr. Joseph Mercola, is that we are now "facing the perfect storm to take us back to the pre-antibiotic age, when some of the most important advances in modern medicine – intensive care, organ transplants, care for premature babies, surgeries and even treatment for many common bacterial infections – will no longer be possible." Read More »
FDA Approves Home Health Platform
Federal regulators have approved Verizon's first foray into the home monitoring space. Read More »
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FDA Clears IND For First Clinical Trial Protocol Developed Using Crowdsourcing
Transparency Life Sciences, LLC (TLS), the world's first drug development company based on open innovation, today announced that its Investigational New Drug Application (IND) to assess lisinopril as an adjunctive therapy for multiple sclerosis (MS) has been cleared by the US Food and Drug Administration (FDA). Read More »
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FDA Fails To Protect Against Antibiotic Resistance, Guarantees More Needless Death And Suffering
Antibiotic-resistant bacteria infect two million Americans every year, causing at least 23,000 deaths. Even more die from complications related to the infections, and the numbers are steadily growing. Read More »
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FDA Fielding App to Track Drug Side Effects During Emergencies
The Food and Drug Administration is building a surveillance app for clinicians and regulators to monitor patients having bad reactions to experimental drugs administered during public health crises, agency officials said.
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FDA Finally Imposes Some Controls On Agricultural Antibiotics. Sort Of.
This morning, the US Food and Drug Administration dropped some long-awaited-but-still-big news regarding the use of antibiotics in meat production. Tl;dr: The FDA asked (but did not compel) the livestock industry to stop using the micro-dose “growth promoter” antibiotics that are widely believed to contribute to increase in antibiotic resistant bacteria in animals, food and humans. Read More »
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FDA Guidance On Medical Device Cybersecurity: Too Little Too Late?
The Food and Drug Administration (FDA) has taken an important step forward in better protecting patients and their data with the release of new guidelines on managing cybersecurity risks of medical devices this week. Despite being a step in the right direction, it unfortunately comes late...
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FDA Hits Tight Timeline for Start of precisionFDA Open Beta
FDA has hit the tight timeline it set itself for the start of the precisionFDA open beta program. The system went live this week, just as the regulator forecast when it started a closed beta program last month. Taha Kass-Hout, chief health informatics officer at FDA, committed to trying to have precisionFDA ready for testing by the end of the year back when the regulator first outlined the project in August. That Kass-Hout was willing to aim for such a timeline--which at the time he described as being "very, very tight"--and then went on to achieve it is testament to the new approach the regulator is taking to IT projects.
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FDA Inaction On Antibiotics Is Making The World Deadlier
This month, the U.S. Food and Drug Administration issued a guidance document (PDF) on the use of antibiotics in farm animals, which accounts for four-fifths of all antibiotics administered in the U.S. [...] The FDA suggests pharmaceutical companies voluntarily change a few labeling and marketing practices to help address that problem. Read More »
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FDA Issues RFQ for Large Scale EHR Study - Wants to Leverage VA's Open Source VistA EHR and Database for Research
The Food and Drug Administration (FDA) yesterday issued a Request for Quotation (RFQ) for a large-scale electronic health record (EHR) system. This RFQ is very important as the objective is to develop a platform to support a critical project by the FDA's Division of Bioinformatics and Biostatistics (DBB) "to conduct research to assess the safety and surveillance of FDA regulated products through the FDA adverse event reporting systems..." Adverse drug reactions are one of the leading causes of death in the US, thus finding which drugs cause negative interactions is of vital importance. The project requires "use of the large electronic medical record (EMR) system..." The project is going to leverage the largest, most comprehensive, and clinically relevant medical records database, that of the US Department of Veterans Affairs (VA).
- The Future Is Open
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FDA Lays Out Rules For Some Smartphone Health Apps
Food and Drug Administration officials say they will begin regulating a new wave of applications and gadgets that work with smartphones to take medical readings and help users monitor their health. Read More »
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FDA Offers Guide On Wireless Healthcare Devices
The Food and Drug Administration has published a guide to the use of wireless healthcare devices in healthcare settings. Read More »
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FDA Partners with Sensato-ISAO and H-ISAC to Create Open Source Cybersecurity Intelligence Network and Resource
The United States Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) has officially executed a tri-lateral agreement between the FDA, the Health Information Sharing and Analysis Center (H-ISAC) and the Sensato-Information Sharing and Analysis Organization (Sensato-ISAO), Sensato announced today. The goal of the agreement is "to ensure that essential medical device or healthcare cybersecurity vulnerability information can be shared with all stakeholders within the HPH Sector, including those who are not members of H-ISAC and Sensato-ISAO," according to a statement from the FDA. "This collaboration will help inform a common understanding of that risk threshold upon which exploit of a vulnerability might impact on patient safety and/or public health."
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