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Imprese · 02/05/20131 min di lettura
Submission of New Drug Application/Abbreviated New Drug Application Field Alert Reports: Notice of Form FDA 3331-Automated Pilot Program
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The Food and Drug Administration (FDA) is announcing a pilot program to test an XML (extensible markup language)-enabled Adobe PDF form, Form FDA 3331--Automated to submit new drug application (NDA) and abbreviated new drug application (ANDA) Field Alert Reports (FARs) as required by FDA regulations. This pilot program is intended to provide FDA with information to allow the Agency to modernize the FAR submission and review pathway and will permit integration with electronic archive filing systems.
Lingua originale della fonte: Federal Register — Food and Drug AdministrationApri il comunicato originale →