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COMPLIANCE POLICY GUIDE (CPG)

Chapter 2 - Biologics December 2019

Final
Issued by:
Guidance Issuing Office
Center for Biologics Evaluation and Research

Sub Chapter 200 - 220: General

Sub Chapter 230: Blood

Sub Chapter 231: Platelets

Sub Chapter 250 - 257: Plasma

Sub Chapter 270 - 275: Non-blood Products

Sub Chapter 280: In Vitro Diagnostic Products - Reagents

Sub Chapter 200 - 220: General

Sub Chapter 230: Blood

Sub Chapter 231: Platelets

Sub Chapter 250 - 257: Plasma

Sub Chapter 270 - 275: Non Blood Products

Sub Chapter 280: In Vitro Diagnostic Products - Reagents


Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

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 comments should be identified with the title of the guidance.

 
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