Notice2021-16187
Electronic Study Data Submission; Data Standards; Technical Rejection Criteria for Study Data Effective Date
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
July 29, 2021
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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).
Indexed from Federal Register on July 29, 2021.
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