About half of all BA/BE studies to support generic drug applications are conducted in India. On the other hand, only about 2% of interventional clinical trials have sites in India. And it does not seem that these numbers will change in the near future. To see the cause for this huge disparity, one needs to … Read more
Can you use a mobile phone to capture endpoints in clinical trials? A study by Clinical Trials Transformation Initiative (CTTI) and FDA found that it could be very hard to develop such endpoints. This week CTTI release detailed recommendations on the process for creating endpoints using mobile phones. Mobile phones can capture a variety of … Read more
Generics drugs are several folds cheaper than innovator drugs, so a realistic way to lower drug prices is to encourage more generic versions of FDA-approved drugs. And finally FDA has taken several concrete steps to do just that. This month FDA announced a new regulatory class of generic drugs called the “Priority generics”. FDA would … Read more
FDA and FTC want consumers to help them find sellers of dietary supplements who make dubious claims or sub-standard products. Seems simple enough, but it is not. The agencies need stronger laws and additional resources to enforce the laws regarding supplements. Consumer complaints are not the answer. Dietary supplements account for about $100 billion sales … Read more
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
