BioCentury
ARTICLE | Politics & Policy

FDA revamps expanded access application

February 5, 2015 2:24 AM UTC

FDA Wednesday released a draft version of a new, simplified form for physicians to request permission for an individual patient to receive access to an unapproved drug.

Peter Lurie, associate FDA commissioner for public health strategy and analysis, wrote in a blog post that the form cut the application time for physicians to 45 minutes from 100 hours. The new form does not alter the criteria for expanded access, including requirements for consent from a product's manufacturer and approval by an institutional review board (IRB). ...