May 22, 2026
It is last weeks news that FDA’s leadership turnover has been the highest in memory, possibly ever. What should concern everyone is the response of industry to this degree of uncertainty at FDA. Drug company Regenxbio last week…Read More
January 7, 2026
The FDA released an update to the Clinical Decision Support Software (CDS software) guidance yesterday (January 6, 2026) in what was a surprise move to virtually all in the FDA regulatory space. To put some historical context on…Read More
September 29, 2023
It has been highly anticipated that FDA was planning to issue a new proposed rule on laboratory developed tests (LDTs) with suggestions that a proposed rule could come in by the end of this week. The expectation clearly…Read More
September 28, 2023
In March 2023, the FDA released a final guidance titled “Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency“, which at high level set out a timeline…Read More
March 8, 2016
IBM (NYSE: IBM) announced last month that Watson Health will gain the ability to analyze the cost and treatment data on more than 200 million patients with the $2.6 Billion purchase of Truven Health Analytics. This comprised the fourth…Read More
October 29, 2015
A flurry of recent reports in the Wall Street Journal, New York Times, Forbes and Reuters regarding Theranos states it is using an unapproved medical device, not adequately following up on customer complaints and suffers from other quality control deficiencies.…Read More
