Providing Regulatory Submissions to the Center for Biologics Evaluation and Research (CBER) in Electronic Format - Biologics Marketing Applications

Docket Number:: FDA-1998-D-0850
Issued by:: Guidance Issuing Office

Center for Biologics Evaluation and Research

This is one in a series of guidance documents intended to assist applicants when making regulatory submissions in electronic format to the Center for Biologics Evaluation and Research (CBER). CBER will update guidance documents on electronic submissions periodically to reflect evolving technology and the experience of those using this technology.

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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-1998-D-0850.

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Providing Regulatory Submissions to the Center for Biologics Evaluation and Research (CBER) in Electronic Format - Biologics Marketing Applications

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