In new Draft Guidance, FDA revises requirements for manufacturers’ distribution of publications about off-label uses for approved drugs or devices.
On March 3, 2014, the Food and Drug Administration (FDA) released a...more
What is new in the world of follow-on biologics?
Manthei: Congress enacted the Biologics Price Competition and Innovation Act of 2009 to provide an alternative to the submission of a Biologics License Application for...more