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.”
Do you think your product may fall into the category of drugs covered by this incentive program? Are you seeking expedited approval for an applicable drug product? We can help you achieve a successful interaction with FDA. To learn more about our services and capabilities, contact us today.
If you have any questions or thoughts on this blog post or others, please contact us today.