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Negócios · 15/09/20031 min de leitura
Guidance for Industry on Investigational New Drug Application Exemptions for Studies of Lawfully Marketed Drug or Biological Products for the Treatment of Cancer; Availability
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Resumo
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled "IND Exemptions for Studies of Lawfully Marketed Drug or Biological Products for the Treatment of Cancer." This guidance clarifies FDA's policy on exemption from investigational new drug application (IND) requirements for studies of marketed cancer drug or biological products. This guidance is intended to decrease the submission of unnecessary IND exemptions.
Idioma original da fonte: Federal Register — Food and Drug AdministrationAbrir o comunicado original →