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Negócios · 09/11/19951 min de leitura

Generic Animal Drug and Patent Term Restoration Act; Ninth Policy Letter; Availability

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Resumo

The Food and Drug Administration (FDA) is announcing the availability of a ninth policy letter, dated June 27, 1995, concerning implementation of the Generic Animal Drug and Patent Term Restoration Act (GADPTRA). The ninth policy letter states the revised policy of the Center for Veterinary Medicine (CVM) on the environmental information to be submitted by sponsors for generic animal drug products. The agency is soliciting comments on the policy letter.

Idioma original da fonte: Federal Register — Food and Drug AdministrationAbrir o comunicado original →

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