CFR 21-600.2-2014
Food and drugs. Part600:Biological products:general. SubpartA:General provisions. Section600.2:Mailing addresses.

Standard No.
CFR 21-600.2-2014
Release Date
2014
Published By
US-CFR-file
Latest
CFR 21-600.2-2014
Scope
(a) Licensed biological products regulated by the Center for Biologics Evaluation and Research (CBER). Unless otherwise stated in paragraphs (c) or (d) of this section, or as otherwise prescribed by FDA regulation, all submissions to CBER referenced in parts 600 through 680 of this chapter, as applicable, must be sent to: Document Control Center (HFM–99), Center for Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852–1448. Examples of such submissions include: Biologics license applications (BLAs) and their amendments and supplements, adverse experience reports, biological product deviation reports, fatality reports, and other correspondence. Biological products samples must not be sent to this address but must be sent to the address in paragraph (c) of this section.

CFR 21-600.2-2014 history

  • 2014 CFR 21-600.2-2014 Food and drugs. Part600:Biological products:general. SubpartA:General provisions. Section600.2:Mailing addresses.
  • 2013 CFR 21-600.2-2013 Food and Drugs. Part600:Biological products: general. Section600.2:Mailing addresses.



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