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  1. Biologics Guidances

Guidance Agenda: Guidance Documents CBER is Planning to Publish During Calendar Year 2019

This is the list of guidance topics CBER is considering for development during Calendar Year 2019.  The list includes topics that currently have no guidance associated with them, topics where updated guidance may be helpful, and topics for which CBER has already issued Level 1 draft guidances that may be finalized following review of public comments.  We currently intend to develop guidance documents on these topics; however, the Center is neither bound by this list of topics, nor required to issue every guidance document on this list.  We are not precluded from developing guidance documents on topics not on this list.

For further information regarding specific topics or guidances, please contact the Office of Communication, Outreach and Development, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002, 1-800-835-4709 or 240-402-8010, ocod@fda.hhs.gov.

 

Guidance Documents CBER is Planning to Issue in 2019

​Guidance Agenda