The U.S. FDA has established new requirements for data standards that will apply to most trial data submitted to FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER). The agency has noted two important dates that determine how a Sponsor should approach and interpret the updated technical rejection criteria.

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This paper will explain the updated technical rejection criteria (TRC) and the impact the updated criteria will have on your submission. It will also make recommendations regarding processes and share points to consider as Sponsors implement and validate against the new criteria.