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GUIDANCE DOCUMENT

Withdrawn Guidances (Biologics) January 2017

Final

Withdrawn Guidances (Biologics)

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

Title Date Issued
(year-month-day)  
Date Withdrawn
(year-month-day) 

Variances for Blood Collection from Individuals with Hereditary Hemochromatosis - Final

2001-08-22

2017-12-07

Precautionary Measures to Reduce the Possible Risk of Transmission of Zoonoses by Blood and Blood Products from Xenotransplantation Product Recipients and Their Intimate Contacts - Draft

2002-11-02

2015-05-08

Criteria for Safety and Efficacy Evaluation of Oxygen Therapeutics as Red Blood Cell Substitutes - Draft

2004-10-28

2015-05-08

Platelet Testing and Evaluation of Platelet Substitute Products - Draft

1999-05-20

2015-05-08

Validation of Growth-Based Rapid Microbiological Methods for Sterility Testing of Cellular and Gene Therapy Products - Draft

2008-02-11

2015-05-08

Use of Serological Tests to Reduce the Risk of Transmission of Trypanosoma cruzi Infection in Whole Blood and Blood Components for Transfusion and Human Cells, Tissues, & Cellular and Tissue-Based Products - Draft

2009-03-26

2015-05-08

Cell Selection Devices for Point of Care Production of Minimally Manipulated Autologous Peripheral Blood Stem Cells - Draft

2007-07-01

2011-08-17

Supplemental Testing and the Notification of Consignees of Donor Test Results for Antibody to Hepatitis C Virus (Anti-HCV) 3/1998" - Final

1998-03-20

1998-10-08

Submitting Type V Drug Master Files to the Center for Biologics Evaluation and Research - Draft

2001-08-23

2010-08-09

 


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:

Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.