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
On May 22, 2017, the European Medicines Agency ("EMA") announced the full functionality of the new EudraVigilance system for the collection and monitoring of suspected adverse reactions with medicinal products that are...more
Years of adverse-event reports documenting problems associated with compromised food, dangerous drugs and harmful cosmetics are now available to the public. The information can be obtained, free of charge, via a downloadable...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