This week the American Heart Association published a report rebuking coconut oil as one of the worst foods for heart health. The internet and new media used this report to thoroughly condemn coconut. Fair or not, this was a great learning moment for food manufacturers on changing fortunes linked to food health claims. The label … Read more
This week FDA released a new guidance describing best practices for using electronic systems in regulated clinical trials and it all but confirms the already standard practice in the industry. However, the guidance will definitely help quality assurance and information technology personnel to enforce electronic hygiene. The guidance is organized in a Q&A format indicating … Read more
Smartphone apps allow users to manage their own health and wellness; and FDA has taken a mostly hands off approach to regulating them. But with new apps being created to capture a variety of use and handling information to diagnose and potential help treat diseases, particularly neurological diseases, FDA may need to step in and … Read more
Less than a few weeks after announcing that it plans to encourage better distribution of funds available for NIH grants, NIH abruptly backed off its announced policy due to a backlash from the affected scientific community, presumably the high rollers who would have been at the receiving end of the cuts. In the previous announcement, … Read more
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
