#6: Expedited Programs for Serious Conditions – Drugs and Biologics
By Kristen Booth
In May 2014, the FDA published a guidance document entitled “Expedited Programs for Serious Conditions – Drugs and Biologics.” The intention of the document was to provide drug makers with an incentive to develop products that fill unmet medical needs for serious conditions. Since its publication, the program established by the guidance document has become an increasingly popular pathway for many companies developing new drug products.
To learn more about this guidance document and its contents, view our previous blog post on the topic, entitled “Taking the Mystery Out Of Expedited Approvals.”