US FDA's Orphan Drug Designation Reviews Often Don't Include Regulatory Histories, GAO Says
Lack of information may mean FDA cannot conduct a thorough review, but HHS argues that products usually are very early in development and therefore don't have a regulatory history to document.
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US FDA Seeking New Orphan Products Office Director Amid Internal Moves
OOPD’s deputy director has been named the acting head of the office responsible for orphan and rare pediatric disease designations.
US FDA Appoints Another Orphan Products Development Office Head Amid Growth Expectations
Janet Maynard will become acting Office of Orphan Products Development director at the end of October, the fourth head of the office in the last 10 months; staff is expected to grow and may begin to provide development advice.
US FDA May Wait Until Late 2019 Before A Cures Hiring Enhancement Is Available
Senior Biomedical Research Service expansion, used to attract elite scientists to federal service, may not be implemented until late 2019; FDA also may have a candidate for OND director.