FDA Study Data Technical Rejection Criteria (TRC): What you need to know!
Автор: U.S. Food and Drug Administration
Загружено: 2021-05-27
Просмотров: 4819
FDA is planning to implement eCTD validations in 2021 specific to submissions containing study data. FDA published the TRC to assist industry in understanding when a submission containing study will be subject to these study data eCTD validations. This recording provides an overview of the TRC, a walk-through of resources currently available to help the sponsor/applicant determine if their submission is subject to these eCTD validations, creation of a simplified TS.XPT, and frequently asked questions.
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