The Humanitarian Use Devices (HUD) form a small group of FDA regulated devices intended to treat rare disease. It is the device equivalent of the orphan drug designation for drug and biologics but much less popular than the orphan drug. There are only 63 HUD devices in the market; each year FDA approved 2-6 of … Read more
What diseases people search for on the internet provides a useful hint to how that information is used. A list of 20 most searched diseases on Google is very surprising; it does not include any life-threatening disease and has a strange mix of indications seldom discussed together. But it points to an important trend. There … Read more
Last week FDA hosted its first conference on cybersecurity of medical devices where more than 100 experts discussed literally every aspect of the security of internet connected medical devices and healthcare delivery organizations (HOD), and the take home message was that medical devices are extremely prone to risk of hacking and there is long way … Read more
If you have young children, you must have a few spinning toys in your home, collectively called the “Fidget” spinners. The sellers of these seemingly innocuous “toys” make claims on their labels that should concern parents and regulators. But so far FDA has not shown any public desire to regulate these products. Fidget spinners are … Read more
In FDA’s long and illustrious history, there are very few watershed moments that can be attributed to one person at the Agency. FDA historians consider the decision by Frances Kelsey to not approve thalidomide in 1960, despite extensive pressure to do so, as one of pivotal moments in its history that defined how it regulates … Read more
This week FDA announced with great fanfare two approval decisions using unique regulatory approaches that would seem to indicate a shift in its thinking about data supporting such decisions. But a careful observation shows that these are baby steps, at best. In the case of Kalydeco, a cystic fibrosis drug, FDA expanded the indication based … Read more
Earlier this month, NIH announced a new policy that would restrict the amount of grant money an individual investigator can hold at any one time. The policy is designed to encourage better distribution of grant money to newer and mid-career investigators. That’s a good first step to better distribute tax-payers money but there are other … Read more
Last week’s worldwide “ransomware” attack, that affected more than 200,000 computers in 150 countries, could have been easily averted if computers had been updated with a software patch released 2 months ago by Microsoft. But is it that simple? Is it fair to blame the victims? Some of the biggest victims were hospitals and other … Read more
Of the 48 major categories of direct-to-consumer (DTC) genetic and genomic tests available to consumers, the tests for ancestry dominate the number of people and tests being done, followed far behind by those for health-related general information. By some estimates in the US alone more than 5 million individuals have had their genomes sequenced for … Read more
This week an article in JAMA reported that about a third of all new drugs approved by FDA in the 10 year period from 2001-2010 had “safety events” after approval which led to about 1% of the drugs being withdrawn from market. This number may be concerning to some, but a careful review of the … Read more
