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ACI: Improving Speed-to-Market for New Chemicals Among Top Association Priorities for 2024

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FDA Roundup: December 19, 2023

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AGG Food & Drug Newsletter - April 2021 | Arnall Golden Gregory LLP

Federal
Register notice finally announcing the fee rates under the Over-the-Counter (OTC) Monograph Drug User Fee Program for Fiscal Year 2021. As we discussed in a previous Bulletin, the CARES Act, among other things, amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) to allow FDA to assess and collect user fees from qualifying owners of OTC monograph drug facilities and qualifying submitters of OTC monograph order requests (OMORs). The fees are meant to support FDA in its OTC monograph drug activities, including inspections of facilities associated with such products. More >
Arbitration as an Alternative to the Backlogged Courts ....

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This Is Not A Drill . . . FDA Publishes Fee Rates Under the Over-the-Counter Monograph Drug User Fee Program for Fiscal Year 2021 | Arnall Golden Gregory LLP

On March 26, 2021, the Food and Drug Administration (FDA) issued a new
Federal
Register notice finally announcing the fee rates under the Over-the-Counter (OTC) Monograph Drug User Fee Program for Fiscal Year 2021.
1 As we discussed in a previous Bulletin, the CARES Act, among other things, amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) to allow FDA to assess and collect user fees from qualifying owners of OTC monograph drug facilities
2 and qualifying submitters of OTC monograph order requests (OMORs).
3 The fees are meant to support FDA in its OTC monograph drug activities, including inspections of facilities associated with such products. ....

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FDA Notice Announcing Increased OTC Monograph Facility Fees

Thursday, April 1, 2021
On March 26, 2021, the FDA updated and reissued the fee rates for the newly created over-the-counter (OTC) monograph Drug User Fee program (OMFUA) for FY2021 in a Federal Register Notice (FRN) titled “
Fee Rates under the Over-The-Counter Monograph Drug User Fee Program for Fiscal Year 2021.” The CARES Act, passed by Congress on March 27, 2020, established OMUFA, FDA’s newest user fee program, which granted FDA the ability to assess and collect two types of fees: OTC monograph drug facility (MDF) fees and OTC Monograph Order Request (OMOR) fees.
The initial notice issued by FDA on December 29, 2020, was quickly withdrawn by the HSS amid controversy surrounding FDA’s plan to collect user fees from manufacturers, including liquor distilleries, that stepped up to meet the US (and world) demand for increased production of hand sanitizers under the Agency’s temporary enforcement policy during the COVID-19 pandemic. ....

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