Orphan Designation Requests To Get Slower Reviews
This article was originally published in The Pink Sheet Daily
FDA can't keep pace with requests, placing more pressure on sponsors to ensure submissions are complete.
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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.
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.
Ilan Irony will take over as acting director of the Office of Orphan Products Development later this month.