Newsletter - December 12, 2019
FDA’s Foreign GMP Audits Are Inadequate, Reports GAO
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 cut corners. Read More
Use of Digital Devices in Clinical Trials Increased About 6 Folds in Last 10 Years
About 1200 currently ongoing clinical trials in the US are using digitally connected tools such as wearable devices and mobile apps. That’s a 6-fold increase from about 200 such trials in 2009. However, with about 22,000 studies ongoing in the US, this is a small fraction of all clinical trials. Read More
FDA’s Foreign GMP Audits Are Inadequate, Reports GAO
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 cut corners. Read More
Use of Digital Devices in Clinical Trials Increased About 6 Folds in Last 10 Years
About 1200 currently ongoing clinical trials in the US are using digitally connected tools such as wearable devices and mobile apps. That’s a 6-fold increase from about 200 such trials in 2009. However, with about 22,000 studies ongoing in the US, this is a small fraction of all clinical trials. Read More
