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OTC Monograph Fees Announced… Not So Fast! | Arnall Golden Gregory LLP


[co-author: David Wilson, Sr. Account Executive, Reed Tech]
On December 29, 2020, the U.S. Food and Drug Administration published a Federal Register notice setting the fee rates under the Over-the-Counter Monograph User Fee Act (OMUFA) Program for Fiscal Year 2021. Reed Tech contributors Carolina Wirth and Genevieve Razick, both of Arnall Golden Gregory, LLP, quickly digested the information and summarized the OMUFA program. More importantly, the authors provided some information regarding the types of facilities that were impacted by these fees. You can read the full bulletin here.
1 However, less than a week later, the Department of Health and Human Services (HHS) published a withdrawal of the notice creating a lot of uncertainty within the industry. According to the withdrawal notice, “FDA lacked the delegated authority” to issue the ....

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AGG Food and Drug Newsletter - January 2021 | Arnall Golden Gregory LLP


On December 29, 2020, the U.S. Food and Drug Administration published a Federal Register notice setting the fee rates under the Over-the-Counter Monograph User Fee Act (OMUFA) Program for Fiscal Year 2021. Reed Tech contributors Carolina Wirth and Genevieve Razick, both of Arnall Golden Gregory, LLP, quickly digested the information and summarized the OMUFA program. More importantly, the authors provided some information regarding the types of facilities that were impacted by these fees. You can read the full bulletin here. However, less than a week later, the Department of Health and Human Services (HHS) published a withdrawal of the notice creating a lot of uncertainty within the industry. According to the withdrawal notice, “FDA lacked the delegated authority” to issue the ....

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FDA slaps craft distilleries with fees for producing hand sanitizer at the onset of the COVID-19 pandemic


FDA slaps craft distilleries with fees for producing hand sanitizer at the onset of the COVID-19 pandemic
Posted
By Nina Rangel
on Thu, Dec 31, 2020 at 12:03 PM
click image
Instagram / rangercreekwhiskey Craft distillers just can’t catch a break this year.
Along with the hardships brought about by the pandemic such as the closure of their tasting rooms the Food and Drug Administration is now telling distilleries that produced hand sanitizer at the start of the pandemic that they ll need to pay a steep fee, the
The FDA is now informing the businesses that, due to a technical detail in recent pandemic relief legislation, they now owe the government more than $14,000, according to the newspaper. ....

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