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GUIDANCE DOCUMENT

Submitting Study Datasets for Vaccines to the Office of Vaccines Research and Review Guidance for Industry; Technical Specifications Document December 2019

Download the Final Guidance Document
Final Level 2 Revised Guidance
Docket Number:
FDA-2018-D-1216
Issued by:
Guidance Issuing Office
Center for Biologics Evaluation and Research

This technical specifications document provides you, sponsor/applicant detailed information and specifications for the content of datasets submitted to FDA’s Center for Biologics Evaluation and Research (CBER) Office of Vaccines Research and Review (OVRR) and is designed to aid clinical and statistical reviewers in the review of vaccine applications, e.g., biologics license applications.  We, FDA, recommend submission of these datasets as part of the applicant’s data tabulation datasets.  The submission of standardized datasets facilitates review and analyses of the data and allows for pooling of data, when appropriate.  These specifications reflect current CBER OVRR thinking, are built to be consistent with the FDA Study Data Technical Conformance Guide , and are generally consistent with the Therapeutic Area User Guide (TAUG) for Vaccines .

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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

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 written comments should be identified with this document's docket number: FDA-2018-D-1216.

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