Providing Regulatory Submissions in Electronic Format- Standardized Study Date: Guide for Industry.

摘要

Under section 745A(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), at least 24 months after the issuance of a final guidance document in which the Food and Drug Administration (FDA) has specified the electronic format for submitting certain submission types to the Agency, such content must be submitted electronically and in the format specified by FDA.2 This guidance and the technical specifications documents it incorporates by reference describe the requirements for an electronic submission of standardized clinical and nonclinical study data under section 745A(a) of the FD&C Act. In accordance with section 745A(a), following the issuance of a final guidance on this topic, study data contained in the submission types identified in this guidance must be submitted electronically in a format that FDA can process, review, and archive. This guidance implements the electronic submission requirements of section 745A(a) of the FD&C Act for study data contained in new drug applications (NDAs), abbreviated new drug applications (ANDAs), biologics license applications (BLAs), and investigational new drug applications (INDs) to the Center for Drug Evaluation and Research (CDER) or the Center for Biologics Evaluation and Research (CBER)3 by specifying the format for electronic submissions. Submissions that are not submitted electronically and electronic submissions that are not in a format that FDA can process, review, and archive will not be filed or received, unless exempted from the electronic submission requirements (see section II.B).