FDA’s GDUFA Guru Is Named Permanent Head Of Office Of Executive Programs
This article was originally published in The Pink Sheet Daily
Mary Beth Clarke, who has been acting director of OEP since April 2012, has been appointed to the post permanently; she oversees numerous programs, including implementation of the Generic Drug User Fee Act.
You may also be interested in...
US FDA final guidance describes possible study design to test whether selected names may misbrand a drug. Agency also okays use of two-letter USAN stems in product names and clarifies use of modifiers.
FDA’s Amy Abernethy describes how agency’s use of real-world data has evolved in response to COVID-19 and the ‘a-ha’ moment of leveraging different data sources to understand the coronavirus. Takeda R&D President Andrew Plump notes difficulties with platform trials and limitations on data sharing.
If Biden administration wants to nominate the acting commissioner, Vacancies Reform Act would dictate the timing. Woodcock can still get the nod and remain head of the agency during the confirmation process, just as Andrew von Eschenbach retained his acting title following his nomination in 2006.