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At FDAImports, we solve the problems involved in bringing products to the highly regulated U.S. market. Our team has over 100 years of direct FDA experience, helping manufacturers, distributors, importers and exporters of regulated products navigate the regulatory maze and successfully enter and stay in U.S. markets.
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In July and August of 2021, the Food and Drug Administration (FDA) announced the revocation of the Emergency Use Authorizations (EUAs) for Gravity Diagnostics, LLC for the Gravity Diagnostics COVID-19 Assay, Materials and Machines Corporation of America for the...
In March of this year, the Center for Drug Evaluation and Research (CDER) branch of the Food and Drug Administration (FDA) implemented a new fee under the OTC Monograph User Fee Program (OMUFA). The fee was required of all facilities that produced OTC monograph drugs...
Effective summer 2021, the Center for Drug Evaluation and Research (CDER) requires confirmation of U.S. Agency assignments for National Drug Code (NDC) drug labeler code requests submitted to the Food and Drug Administration (FDA). If the U.S. Agent has not been...