iwewlkws 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by FDA in the 10 year period from 2001-2010 had “safety events” after approval which led to about 1% of the drugs being withdrawn from market.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
This week, FDA and NIH released a template for clinical trial protocols that practically took away any excuses one may have to not write a good quality clinical protocol. This template was jointly developed by clinical trial experts at NIH and FDA for government-funded researchers, in collaboration with a non-profit group that was developing a … Read more
This week FDA released a Warning Letter* issued to a GMP vendor in India that points to a very important issue that all companies using vendors, specifically foreign vendors, should be aware of, namely, who is listed as the manufacturer on the Certificate of Analysis (COA). Is the vendor being truthful about its sub-vendors and … Read more
Clinical trial populations are not very diverse. Minority populations form a very small fraction of the trial populations, much below their proportion in the US population leading to concerns about the effectiveness of approved products in populations under-represented in clinical trials. Since 2014, FDA’s Action Plan to Enhance the Collection and Availability of Subgroup Data requires … Read more
