I Wish I Knew What I Know Now: Conversations with AGG on FDA Issues - Quality Agreements for FDA-Regulated Products: Looking Under the Hood
Podcast: Non-binding Guidance: SEC Disclosure Issues for Life Sciences Companies
In prior posts here and here, I analyzed new data obtained from FDA through the Freedom of Information Act about FOIA requests. I looked at response times and then started to dive into the topics that requesters were asking...more
Governor Pritzker recently signed into law Public Act 101-0455 amending the School Safety Drill Act (105 ILCS 128/1) to require threat assessment procedures and the creation of threat assessment teams in school districts...more
On June 2, 2014, the Food and Drug Administration launched openFDA, a program designed to improve access to publicly available data beginning with adverse event reports. While greater accessibility to adverse event reports...more
Information is power, and as of this month, there’s a new power source of information about drug effects. openFDA.gov is an initiative of the U.S. Food and Drug Administration to expand access to and use of reports of...more
As part of the Obama administration's effort to make public information more accessible, the FDA launched openFDA on June 2, 2014. This new database makes nearly 4 million pharmaceutical adverse event reports the FDA...more