21 CFR Part 600 Guidelines for Biological Products: General
(A) Licensed biological products regulated by the Center for Biologics Evaluation and Research (CBER). Unless otherwise stated in paragraph (c) 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: Food and Drug Administration, Center for Biologics Evaluation and Research, Document Control Center, 10903 New Hampshire Ave., Bldg. 71, Rm. G112, Silver Spring, MD 20993-0002. Examples of such submissions include: Biologics license applications (BLAs) and their amendments and supplements, 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.
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Table of Contents
Subpart A - General Provisions
Subpart B - Establishment Standards
600.11 Physical establishment, equipment, animals, and care.
600.14 Reporting of biological product deviations by licensed
manufacturers.
600.15 Temperatures during shipment.
Subpart C - Establishment Inspection
Subpart D - Reporting of Adverse Experiences
600.80 Postmarketing reporting of adverse experiences.
600.82 Notification of a permanent discontinuance or an interruption in
manufacturing.
21 CFR Part 600 Guidelines for Biological Products: General:
