[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
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