22/11/2022 Other Services
For FY 2023, the FDA generic drug User Fee rates are: ANDA ($240,582), DMF ($78,293), domestic API facility ($37,544), foreign API facility ($52,544), domestic FDF facility ($213,134), foreign FDF facility ($228,134), domestic CMO facility ($51,152), foreign CMO facility ($66,152), large size operation generic drug applicant program ($1,620,556), medium size operation generic drug applicant program ($648,222), and small business generic drug applicant program ($162,056).
These fees will remain in effect through September 30, 2023.
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For FY 2023, the United States FDA generic drug User Fee rates are: ANDA ($240,582), DMF ($78,293), domestic API facility ($37,544), foreign API facil...
For FY 2023, the FDA generic drug User Fee rates are: ANDA ($240,582), DMF ($78,293), domestic API facility ($37,544), foreign API facility ($52,544),...
FDA Registration is required before shipping any regulated product to the United States, to avoid the detention of your shipment by the U.S. Food and ...
Human Drugs regulatory activities account for 33 percent of FDA’s budget, and 65 percent of these activities are paid for by industry user fees. ITB H...
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