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AABB > Press Room > Comments

Comments 

This section contains comments that have been submitted to the government docket on issues of concern to the transfusion medicine and cellular therapies communities. Click on a link below to read current comments. For access to past comments, check our archive.

Comments to FDA on “Draft Guidance for Industry: Use of Donor Screening Tests To Test Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products for Infection With Treponema pallidum (Syphilis)” - 1/31/14
Comments to FDA on “Draft Guidance for Industry: Use of Nucleic Acid Tests To Reduce the Risk of Transmission of West Nile Virus From Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products” - 1/21/2014
Comments to FDA on the Proposed Rule “Permanent Discontinuance or Interruption in Manufacturing of Certain Drug or Biological Products" – 1/3/14
Comments to CMS on the Proposed Rule “Changes to CLIA Enforcement Actions for Proficiency Testing Referral” - 11/18/13
Comments to FDA on the Draft Guidance for Industry for BLAs for Minimally Manipulated HPC, Cord Blood – 9/16/13
Comments to FDA on the Draft Guidance for Industry and FDA Staff for INDs for Minimally Manipulated HPC, Cord Blood – 9/16/13
Comments to FDA on “Draft Guidance for Industry on Contract Manufacturing Arrangements for Drugs: Quality Agreements”  – 7/29/13
Comments to CMS on the Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long Term Care Hospital Prospective Payment System for Proposed FY 2014 Rates – 6/25/13
Joint Comments to FDA on the Draft Guidance on Recommendations for Screening, Testing, and Management of Blood Donors and Blood and Blood Components Based on Screening Tests for Syphilis - 5/22/13
Comments to FDA on “Draft Guidance for Industry: Preclinical Assessment of Investigational Cellular and Gene Therapy Products” - 2/26/13
Comments to FDA on the “Unique Device Identification System” - 11/07/12
Joint Comments to FDA on the Draft Guidance on Recommendations for Donor Questioning, Deferral, Reentry and Product Management to Reduce the Risk of Transfusion-Transmitted Malaria - 8/31/12
Comments to HHS: RFI on Design of a Pilot Operational Study to Assess Alternative Blood Donor Deferral Criteria for MSM - 6/11/12
Comments to FDA on “Draft Guidance for Industry: Implementation of Acceptable Abbreviated Donor History Questionnaire and Accompanying Materials for Use in Screening Frequent Donors of Blood and Blood Components.” - 1/23/12 (PDF)
Comments to FDA on Bar Code Technologies for Drugs and Biological Products  - 1/9/12
Comments to CDC on Public Service Guideline for Reducing Transmission of HIV, HBV and HCV Through Solid Organ Transplantation - 12/22/11
Joint Comments on Exceptions to FDA Sterility Testing Requirements (21 CFR 610.12) – 9/16/11
Comments on Amendments to FDA Sterility Testing Requirements for Biological Products (21 CFR 610.12) – 9/16/11
Comments to FDA on the Draft Guidance for Pre-Storage Leukoreduction of Whole Blood and Blood Components – 4/27/11
Comments to FDA on Workshop Exploring Track and Trace System for Finished Prescription Drug Products – 4/15/11
Comments to CMS on Hospital Outpatient Prospective Payment System Proposed Rule for Calendar Year 2011 – 8/30/10
Comments to CMS on Proposed Changes to the Hospital Inpatient Prospective Payment Systems and Fiscal Year 2011 Rates – 6/17/10
Comments to Plasma Protein Therapeutics Association on Recovered Plasma Specification Draft – 4/14/10
Comments to FDA on Transparency Task Force Initiatives – 4/12/10
Comments: Questions From Cord Blood Licensure Workshop Submitted to FDA Docket – 4/8/10 – 4/8/10 (PDF)
Comments to FDA on Proposed Rule on Informed Consent Elements – 2/25/10
Comments to FDA for Draft IND Guidance on HPC-Cs – 01/14/10
Comments to FDA on Draft Guidance on Blood Donor Suitability and Blood Safety and H1N1 Pandemic - 12-3-09
Comments to CMS on Proposed 2010 Outpatient Payments for Blood Products – 08/31/09
Comments to CMS on Proposed 2010 Outpatient Payments for Stem Cell Procedures – 08/28/09 (PDF)
AABB Commends CMS for Recognizing Blood Costs in Inpatient Market Basket - 6/30/09
Comments to FDA on Draft Guidance for Use of Serological Tests to Reduce Transmission Risk of T. cruzi Infection – 6/15/09
Comments to FDA on cGTP and Additional Requirements for Manufacturers of HCT/Ps – 4/14/09
Amended Comments to the FDA on SNIs and the National Drug Code – 4/6/09
Comments to FDA on Adverse Event Reporting in Flu Pandemic – 2/9/09 (PDF)
Comments to FDA on SNIs and the National Drug Code – 2/9/09 (PDF)

 
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