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Zdrowie i gospodarka · 29.02.2012

Electronic Submission of Nonclinical Study Data; Notice of Pilot Project

The Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER) is announcing an invitation to participate in a pilot evaluation program to test the electronic submission of nonclinical study data using the Standard for Exchange of Nonclinical Data (SEND), a new electronic data standard format, which can be used to support review activity. Participation in the pilot program is open to all sponsors. The pilot program is intended to provide industry and CBER regulatory review staff the opportunity to evaluate SEND and determine if it facilitates the submission process of nonclinical study data related to investigational new drug applications (INDs).

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