US FDA’s First OTC Monograph Program User Fee Schedule Delayed For HHS Secretary’s Signature
Questions On Firms Subject To Fees Surfaced Immediately After Publication
Rates published in December for FY2021 monograph user fee program prompted immediate questions and opposition. HHS says fee schedule is being withdrawn because the document “was issued without approval of the Secretary.”
You may also be interested in...
The FDA says the new OTC monograph drug user-fee program (OMUFA) will provide additional resources needed to support the streamlined regulatory activities described by OTC drug reform legislation enacted in March 2020.
More than 6.2m containers of sanitizers have been recalled since mid-October due to methanol contamination. Total includes 67,440 made by Genesis Partnership Co., the first manufacturer in Guatemala that the FDA identified as making contaminated hand sanitizers distributed in the US.
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.