By: Scott Gottlieb, M.D. The key to FDA’s public health mission, and its ability to bring innovative new therapies to patients, is the technical, scientific, and clinical expertise of its people. As the products that we’re asked to review become more complex and specialized, so do the technical demands on our workforce. Our staff must […]
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Australian TGA to handle medical device advertising complaints
By Stewart Eisenhart, Emergo Group The Australian Therapeutic Goods Administration (TGA) plans to roll out “simplified and improved arrangements” for managing complaints regarding medical device and drug advertising. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do not necessarily reflect those […]
Medical device R&D investments expected to rise through 2018
By Stewart Eisenhart, Emergo Group An Emergo survey of medical device companies finds that a higher percentage of smaller firms plan to increase their research and design spending over the next year than mid- and large-sized firms. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are […]
Chinese regulators starting medical device clinical trial inspection program
By Stewart Eisenhart, Emergo Group The China Food and Drug Administration (CFDA) plans to begin conducting on-site inspections of clinical trials for medical devices in an effort to improve clinical data used in premarket review decisions. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the […]
FDA collaborates to promote safety, quality in clinical trials done in India
By Leslie Ball, M.D., Letitia Robinson, Ph.D., R.N, and Elizabeth Wiley, M.D., J.D., M.P.H. After more than 16 hours of travel, we touch down in Mumbai late in the evening and are greeted by a wave of heat and humidity as we exit the airport terminal. As we drive from the airport to the hotel, […]
Two recent scientific advances underscore an encouraging future for precision medicine at FDA
By: Janet Woodcock, M.D. FDA helps bring precision medicine – in the form of targeted therapies — to people living with diseases that have specific genetic features. Two recent FDA drug approvals point to an encouraging future for “precision medicine” — an approach for disease treatment that tailors medical therapies, including medications, to the needs […]
FDA recognizes UL 2900 cybersecurity standards
By Stewart Eisenhart, Emergo Group A set of standards published by UL to address medical device cybersecurity issues will soon be adopted by the US Food and Drug Administration to help manufacturers support security assurance claims. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the […]
Brazil adds Irish Standards Authority to accredited list of MDSAP auditors
By Stewart Eisenhart, Emergo Group Brazilian medical device regulators have recognized the National Standards Authority of Ireland (NSAI) as accredited to conduct quality system audits under the Medical Device Single Audit Program (MDSAP). Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and […]
India CDSCO draft clarifies medical device, IVD registrations
By Stewart Eisenhart, Emergo Group Indian medical device market regulators have published a new draft list of medical devices that clarifies how they’ll be classified under the new Medical Device Rules 2017. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do […]
How FDA plans to help consumers capitalize on advances in science
By: Scott Gottlieb, M.D. We’re at a point in science where new medical technologies hold out the promise of better treatments for a widening number of vexing conditions. Over the last few decades, science has enabled fundamental advances in our understanding of the genetic and protein bases of human disease. These developments are already being […]
