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Imprese · 09/04/20021 min di lettura
Draft Guidance for Industry on IND Exemptions for Studies of Lawfully Marketed Cancer Drug or Biological Products; Availability
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Riepilogo
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "IND Exemptions for Studies of Lawfully Marketed Cancer Drug or Biological Products." This guidance clarifies FDA's policy on exemption from investigational new drug (IND) application requirements for studies of marketed cancer drug or biological products. This guidance is intended to decrease the burden to investigators and regulators of submitting unnecessary IND applications.
Lingua originale della fonte: Federal Register — Food and Drug AdministrationApri il comunicato originale →