Tier 1: $517,381
Tier 2: $103,476
- Company Registration
- Product Listing
- U.S. Agent Service
FDA recognizes that the FY 2022 facility fee rates were an increase of 19 percent in comparison to the FY 2021 facility fee rates, and that increase was largely attributed to the decrease in the number of fee-liable facilities.
Any lessons learned for the FY 2023 facilities rates? Not really.
The CARES Act requires FDA to report annually on its progress in achieving the goals identified in the Over-the-Counter Monograph Drug User Fee Program (OMUFA) performance goals and procedures document.
Effective December 31, 2021, companies manufacturing alcohol-based hand sanitizers under the temporary policies must cease production of these products.
Hand sanitizers manufactured before or on December 31, 2021, and produced under the temporary guidance can no longer be sold or distributed by manufacturers after March 31, 2022.