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Zdrowie i gospodarka · 14.05.1999

Foreign Establishment Registration and Listing

The Food and Drug Administration (FDA) is proposing to amend its regulations pertaining to the registration of foreign establishments and the listing of human drugs, animal drugs, biological products, and devices. The proposal would require foreign establishments whose products are imported or offered for import into the United States to register with FDA. The proposal would also require foreign establishments to identify a United States agent and would describe some of the agent's responsibilities. The agency is proposing these changes to implement section 417 of the Food and Drug Administration Modernization Act of 1997 (FDAMA) as it pertains to foreign establishment registration.

Source: Federal Register — Food and Drug AdministrationOpen original release →