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...
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Medical Device Cybersecurity: manufacturers must design, develop, and maintain processes and procedures to provide a reasonable assurance that the dev...
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FDA will use the information provided with the Prior Notice to determine whether to inspect, sample the article of food when it arrives in the U.S. or...
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