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GUIDANCE DOCUMENT

Providing Regulatory Submissions to the Center for Biologics Evaluation and Research (CBER) in Electronic Format - Biologics Marketing Applications Guidance for Industry November 1999

Download the Final Guidance Document Read the Federal Register Notice
Final
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.

Submit Comments

Submit Comments Online

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.

Questions?

Contact Point
Office of Communication, Outreach and Development (OCOD)
Center for Biologics Evaluation and Research
Food and Drug Administration
10903 New Hampshire Ave WO71-3128
Silver Spring, MD 20993-0002
ocod@fda.hhs.gov
(800) 835-4709
(240) 402-8010
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