FDA Wants Tests of New Data Submission Standard
The Food and Drug Administration is seeking pilot participants to test electronic submission of non-clinical study data using a new standard.
The Food and Drug Administration is seeking pilot participants to test electronic submission of non-clinical study data using a new standard.
The FDA Center for Biologics Evaluation and Research worked with the Clinical Data Interchange Standards Consortium to develop the Standard for Exchange of Non-clinical Data, or SEND. “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 non-clinical study data related to investigational new drug applications,” according to a notice published Feb. 29.
CBER recently adopted a standard for clinical study data. Companies developing biological products also submit non-clinical data from animal studies in support of applications for approval of human drugs.
The FDA Center for Biologics Evaluation and Research worked with the Clinical Data Interchange Standards Consortium to develop the Standard for Exchange of Non-clinical Data, or SEND. “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 non-clinical study data related to investigational new drug applications,” according to a notice published Feb. 29.
CBER recently adopted a standard for clinical study data. Companies developing biological products also submit non-clinical data from animal studies in support of applications for approval of human drugs.
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