15/09/2023 Other Services
OTC Drug products: 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 upcoming FY 2023 facilities rates?
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If your Canadian, French or Italian company's products are any of the following, then an OTC Drug Establishment Registration is required, and not MoCR...
Foreign suppliers must first register with the United States Food and Drug Administration (FDA). Also, there is a listing requirement for medical devi...
Entities that registered with the FDA during the Coronavirus Disease 2019 (COVID-19) pandemic, and whose sole activity with respect to OTC monograph d...
U.S. FDA regulated products. Before you export or import them, make sure the manufacturers are registered with the U.S. Food and Drug Administration. ...
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