10/03/2023
“Power tends to corrupt and absolute power corrupts absolutely.” (Lord Acton in 1887) [Analysis by Jim Dickinson] Supp...10/13/2020
FDA has renewed and expanded its licenses of Certara’s biosimulation software with more than 400 user licenses of the compan...09/22/2020
[Report by Jim Dickinson] Years of complaints about the adequacy of CDRH device labeling requirements are echoed in a new raft of ...12/14/2015
Federal Register Notice: FDA’s Circulatory System Devices Panel of the Medical Devices Advisory Committee will meet 2/18/16,...12/10/2015
Federal Register Notice: FDA is seeking public comment on a proposed information collection involving interviews of pharmaceutical...12/10/2015
Federal Register Notice: FDA has determined the regulatory review period for Napo Pharmaceuticals’ Fulyzaq is 7,784 days for...12/10/2015
Federal Register Notice: FDA has determined the regulatory review period for Janssen Pharmaceutica’s Sirturo is 2,213 days f...12/10/2015
Federal Register Notice: FDA has determined the regulatory review period for Bristol-Myers Squibb’s Eliquis is 3,685 days fo...