FDA User Fees Should Be On Chopping Block – Legal Luminary Hutt
This article was originally published in The Gray Sheet
FDA user fees are destructive to the agency's mission and should be discontinued, says Washington attorney and FDA expert Peter Barton Hutt
You may also be interested in...
CDRH is not equipped to understand the science behind many cutting-edge device technologies, says a Nov. 29 report from the Subcommittee on Science and Technology, an ad hoc panel of the FDA Science Board
Office of New Drugs Director Peter Stein said in an interview that a large amount of coronavirus-related work is arriving at the FDA, but so far staff are keeping up.
Akero’s FGF21 analog yields 63%-72% relative hepatic fat reduction in Phase IIa study; the company awaits biopsy data hoping to see a fibrotic benefit. Also, Genfit says COVID-19 pandemic should not significantly delay its Phase III NASH readout.