FDA issues draft guidance on drug development in rare diseases

This draft guidance is open for comments for the next 60 days.

This guidance assists sponsors of drug and biological products intended to treat or prevent rare diseases in conducting more efficient and successful development programs through a discussion of selected issues commonly encountered in rare disease drug development. Although similar issues are encountered in other drug development programs, they are frequently more difficult to address in the context of a rare disease with which there is often little medical experience.

Read the pdf
Copyright Widler & Schiemann AG 2015. All Rights Reserved. /