At US FDA, Adding ‘Effective’ Staff For Overhauled OTC Monograph Program ‘Really Takes Time’
CDER’s Office of Nonprescription Drugs is “hitting the deck running’” hiring and training staff following passage of OTC monograph reform with user fees to support adding staff and a reshuffling earlier in 2020, says Peter Stein, Office of New Drugs director.
You may also be interested in...
“Who would have said that, looking forward two or three years ago, we would be where we are now?” says FDA OTC office director Theresa Michele. Monograph reform and introducing “additional conditions for nonprescription use” options for NDA OTCs each is a “real gamechanger.”
OMORs to FDA also will cost more under the FY2022 OMUFA rates published in Federal Register notice, which sets total facility registration fees at nearly $23.9, up from nearly $23.3m for FY2021.
Firms making OTC monograph drugs won’t have to pay facility fees twice during FY2021, says Theresa Michele, FDA Office of Nonprescription Drugs director.