FDA Study Data Technical Rejection Criteria (TRC): What you need to know! - 05/21/2021 - 05/21/2021

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.
Source: FDA Center for Drug Evaluation and Research - What's New - Category: Drugs & Pharmacology Authors: Source Type: news