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GUIDANCE DOCUMENT

Providing Regulatory Submissions in Electronic Format -- Standardized Study Data December 2014

Final
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research

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. 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.


Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.