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 ...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Federal Register Notice: FDA is making available a revised draft guidance for industry entitled Health Document Submission Require...09/09/2016
Federal Register Notice: FDA is making available a draft guidance entitled E17 General Principles for Planning and Design of Multi...09/09/2016
Federal Register Notice: FDA will hold a meeting of the Blood Products Advisory Committee 11/17 from 8 a.m. to 5:30 p.m. and 11/18...09/09/2016
Federal Register Notice: FDA will hold a meeting of the Science Advisory Board to the National Center for Toxicological Research (...09/09/2016
Federal Register Final rule: FDA is amending 21 CFR 17.2 to remove the maximum civil money penalties table associated with statuto...