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Zdrowie i gospodarka · 29.07.2021

Electronic Study Data Submission; Data Standards; Technical Rejection Criteria for Study Data Effective Date

The Food and Drug Administration's (FDA or Agency) Center for Biologics Evaluation and Research (CBER) and Center for Drug Evaluation and Research (CDER) are announcing the effective date for Electronic Common Technical Document (eCTD) validations referenced in FDA's "Technical Rejection Criteria for Study Data" (TRC).

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