iwewlkws 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by FDA in the 10 year period from 2001-2010 had “safety events” after approval which led to about 1% of the drugs being withdrawn from market.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
This week FDA announced that it sent Warning Letters to 14 manufacturers of about 65 dietary supplements making claims to treat cancer. One wonders what triggered this event and why did it take this long as obviously these companies did not spring up overnight. FDA’s news release about this event painted a rather innocent picture; … Read more
The regulators publish lists of common deficiencies to create awareness about the kind of concerns raised by auditors in a given period. Such lists are useful to understand the common areas of error and may help reduce those findings in future at other organizations. Few weeks back, MHRA, the regulators in the UK, published common … Read more
