iwewlkws The GAO reports this week that FDA is severely short of inspectors capable of auditing foreign sites, it gives up to 12 weeks’ notice to foreign sites prior to inspections giving them ample opportunity to clean-up and cover deficiencies, and its inspectors for foreign sites are given inadequate time to complete their job making them … Read more
A perspective in the Journal of American Medical Association (JAMA) presents the unique challenge faced by medical professionals regarding use of CBD products by their patients. CBD products tread a fine line between legal and illegal products. Without any specific disease claims, CBD containing products can be sold as cosmetics or supplements. On the other … Read more
Last week FDA released the final guidance document for adaptive trials for drugs and biologics and it contains mostly the same information as the previous guidance documents by the Agency on the topic with some small but critical recommendations. FDA expects the sponsors to include the statistical analysis plan, the Data Monitoring Committee (DMC) charter, … Read more
Two new drug approvals for rare and life-threatening diseases, both with the Breakthrough therapy designations, show how it is getting common from FDA to approve new drugs based on single clinical trials with smaller sample sizes. The first case is a drug invented in China for a rare cancer, mantle cell lymphoma, was approved based … Read more
Last week’s FDA Warning Letter to Dollar Tree stores should act as a warning to all companies that use contract manufacturers particularly that using overseas manufacturers of FDA regulated products. Dollar Tree’s problems relate to its failure to verify the GMP compliance status of its vendors and failure to heed FDA’s repeated notifications of the … Read more
To export a medical device from US to another country, the manufacturers need the Export Certificate, called the Certificate to Foreign Government (CFG) to clear customs. Most CFGs are issues without much hitch but there are times when FDA denies a CFG for either the device being exported is just to injunction proceedings or seizures … Read more
This week we found that Google has been going through the personal medical data from millions of patients without the patients and most of their doctors knowing about it. Google made a deal with a major hospital system to share private patients data to be used to create new products. A deeper dive shows that … Read more
In its ongoing reorganization efforts to align the review and oversight activities with the changing landscape of the products it regulates, FDA announced a major reorganization of its oncology product review divisions by renaming the main office to Office of Oncologic Diseases (ODD) and creating 6 new divisions within the office each focused on fewer … Read more
Health algorithms used to manage health decisions could lead to erroneous outcomes if data used to build and or train them is biased. This is particularly a concern since most health algorithms do not require a formal FDA approval particularly if they are labelled as MDDS products. A recent report demonstrated how a widely used … Read more
A joint government task force lead by FDA to study the causes of drug shortages found that these shortages occur primarily because the manufacturers are unable to charge higher prices for their drugs even when there is a shortage and that it takes a longer than anticipated time to catch-up once a drug is in … Read more
