CRED Practical Document Writing and Management

Structure

Need to meet Technical Conformance Guides eCTD Technical Conformance Guide (Guide) provides specifications, recommendations, and general considerations on how to submit electronic Common Technical Document (eCTD) based electronic submissions to the Center for Drug Evaluation and Research (CDER) or the Center for Biologics Evaluation and Research (CBER) 745A(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) with respect to electronic submissions for certain investigational new drug applications (INDs); new drug applications (NDAs); abbreviated new drug applications (ANDAs); certain biologics license applications (BLAs); and master files submitted to CDER or CBER. https://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess /FormsSubmissionRequirements/ElectronicSubmissions/UCM465411.p df