Remove keyword biologics
article thumbnail

Overview of FDA Expedited Development and Approval Programs for Serious Conditions

Impact Pharmaceutical Services

In May of 2014 and February of 2019 , the FDA released final Guidance for Industry outlining the Agency’s policies and procedures regarding expedited development and review programs for new drugs and biologics intended to treat serious or life-threatening conditions. Image courtesy of qimono at pixabay.com.

FDA 52