Prahsant Kumar

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

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