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 ...06/20/2018
by: Robert Brooks Several stakeholders are raising issues related to an FDA docket on quality considerations for metered dose inha...04/27/2017
[Analysis by Jim Dickinson] “FDA is a slow-moving target that bleeds profusely when hit.” (Conventional wisdom from fo...03/13/2017
[Editorial by Jim Dickinson] For the first time in our 35-year history as the oldest FDA-centered news publisher, Dickinson’...09/09/2016
Federal Register Notice: FDA is making available a revised draft guidance for industry entitled Health Document Submission Require...09/09/2016
Federal Register Notice: FDA is making available a draft guidance entitled E17 General Principles for Planning and Design of Multi...