US FDA still getting to grips with REMS
This article was originally published in SRA
Executive Summary
The US pharmaceutical industry is concerned that the Food and Drug Administration is failing to meet its performance goals under the prescription drug user fee programme (PDUFA IV) because the agency is being slowed down by the implementation of the FDA Amendments Act, particularly with respect to risk evaluation and mitigation strategies1. At the Drug Information Association’s 45th annual meeting held in San Diego, US, on 21-25 June, Sandra Kweder, deputy director of the Office of New Drugs in the agency’s drugs centre, admitted that PDUFA deadlines had been affected in the past year as implementation had been a challenge.