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Regulatory Updates

​This section serves as a quick reference for regulatory updates announced in AABB Weekly Report. If you have questions, please contact the Regulatory Affairs Staff at regulatory@aabb.org.

AABB Accepting Questions for ‘Ask the FDA’ Session at the 2019 Annual Meeting – 06/21/19

REGULATORY UPDATE: FDA Issues Draft Guidance on Biotin Interference – 06/21/19

REGULATORY UPDATE: Medication Deferral List Updated – 06/14/19

REGULATORY UPDATE: CDC Publishes Report on Sepsis Attributed to Bacterial Contamination of Platelets – 06/14/19

REGULATORY UPDATE: AABB FDA Liaison Meeting Summary Available – 06/14/19

REGULATORY UPDATE: 2019 Spring Unified Agenda Published – 06/07/19

REGULATORY UPDATE: New Variance Approval under 21 CFR 640.120 – 06/07/19

REGULATORY UPDATE: FDA Issues Recall of Beckman Coulter Analyzers Related to Erroneous Platelet Counts – 05/24/19

REGULATORY UPDATE: FDA Issues Final Babesia Guidance – 05/10/19

FDA Releases 2017 Report on Fatalities Following Blood Collection and Transfusion – 05/10/19

REGULATORY UPDATE: FDA Approves Exception to Malaria Travel Deferral for Certain Collections – 04/26/19

REGULATORY UPDATE: FDA Issues Important Information on Recent Reports of Septic Transfusion Reactions Related to Acinetobacter Contamination of Platelets – 04/19/19

Ebola Virus Update – 04/19/19

REGULATORY UPDATE: FDA Posts Final Materials and Webcast of March 2019 BPAC Meeting – 04/05/19

REGULATORY UPDATE: Changes in Inspection Regulations Effective May 2019 – 04/05/19

REGULATORY UPDATE: AABB Posts Summary of Recent BPAC Meeting – 03/29/19

REGULATORY UPDATE: FDA Issues Statement on Pathogen Reduction Technologies – 03/29/19

FDA Releases Guidance Document, “Standards Development and the Use of Standards in Regulatory Submissions Reviewed in the Center for Biologics Evaluation and Research” – 03/29/19

BPAC Considers Future Approaches for ZIKV Testing and MSM Deferral Policies – 03/22/19

REGULATORY UPDATE: Joint Comments Submitted on Bacterial Risk Control Draft Guidance – 03/15/19

REGULATORY UPDATE: FDA Will Revisit ZIKV Testing Requirements and MSM Deferral Policies – 03/08/19

REGULATORY UPDATE: CBER Publishes Updated 21 CFR 640.120 Approvals – 03/08/19

REGULATORY UPDATE: FDA Issues Statement of Caution for Infusion of Young Donor Plasma – 03/01/19

Consolidated Appropriations Act, 2019 Requires FDA to Finalize Guidance on Bacterial Risk Control Strategies – 03/01/19

REGULATORY UPDATE: CBER Publishes 2019 Guidance Agenda – 03/01/19

REGULATORY UPDATE: FDA Announces Upcoming BPAC Meeting – 02/15/19

AABB Releases Ebola Toolkit as Exclusive Member Offering – 02/15/19

REGULATORY UPDATE: FDA Approves Grifols Procleix Babesia Assay – 02/08/19

Checklist for Historic Antigen Labeling Now Available as Exclusive Member Offering – 01/18/19

REGULATORY UPDATE: Health Care Worker Monitored for Possible Ebola Exposure - 01/11/19

Ebola Virus Update - 12/21/18

REGULATORY UPDATE: FDA Releases Recommendations for Labeling of Red Blood Cells with Historical Antigen Typing Results – 12/21/18

REGULATORY UPDATE: Cesium Irradiator Replacement Project Supported by New Law – 12/21/18

REGULATORY UPDATE: AABB Requests Member Comments on Bacterial Risk Control – 12/14/18

REGULATORY UPDATE: 'Ask the FDA and CLIA/CMS' 2018 Annual Meeting Session Slides Now Available – 12/14/18

REGULATORY UPDATE: FDA Releases New Bacterial Risk Control Draft Guidance, Approves Additional 510(k) Clearance for Culture of Platelets – 12/07/18

AABB Updates Zika Virus Biovigilance Network to Incorporate FDA’s July 2018 Guidance – 12/07/18

REGULATORY UPDATE: FDA to Modernize 510(k) Clearance – 11/30/18

FDA Workshop Highlights Pathogen-Reduction Technology – 11/30/18

Ebola Virus Update - 11/16/18

REGULATORY UPDATE: FDA Issues Draft Dried Plasma Guidance – 11/09/18

REGULATORY UPDATE: AABB Continues to Monitor CDC Reports on Ebola Risk – 10/26/18

FDA Approves New DNA-based Blood Compatibility Test – 10/12/18

REGULATORY UPDATE: CBER Updates Secure Email Policy – 10/05/18

REGULATORY UPDATE: AABB, ABC and ARC Submit Comments on FDA’s Babesiosis Draft Guidance – 10/05/18

REGULATORY UPDATE: FDA Issues Two Draft Guidances – 09/28/18

REGULATORY UPDATE: FDA Updates eBER System – 09/28/18

REGULATORY UPDATE: FDA Issues Updated 2018 Guidance Agenda – 09/21/18

OBRR to Host Public Workshop on Pathogen Reduction – 09/14/18

AABB Releases Circular of Information User Guide as Exclusive Member Offering – 09/14/18

Nicole Verdun Named Director, Office of Blood Research and Review – 08/31/18

Reminder: ZIKV Testing Tool Kit Available – 08/31/18

REGULATORY UPDATE: Haemonetics Issues Urgent Recall of Leukotrap RC System – 08/31/18

Reminder: AABB Accepting Questions for "Ask the FDA" Session at the 2018 Annual Meeting – 08/17/18

AABB Accepting Questions for "Ask the FDA" Session at the 2018 Annual Meeting – 08/03/18

REGULATORY UPDATE: FDA Issues Draft Babesia Guidance – 07/27/18

REGULATORY UPDATE: AABB Posts Summary of Recent BPAC Meeting – 07/27/18

2018 CBER Science Symposium Videos Available – 07/20/18

FDA Releases 2017 Biological Product Deviation Report Summary – 07/20/18

BPAC Weighs in on Multiple Strategies for Minimizing Bacterial Contamination in Platelets – 07/20/18

REGULATORY UPDATE: FDA Grants Emergency Use Authorization for Freeze-Dried Plasma for U.S. Military Personnel – 07/13/18

REGULATORY UPDATE: AABB Posts Analysis of FDA Zika Virus Guidance – 07/13/18

REGULATORY UPDATE: Synthetic Cannabis and Anticoagulants – 07/13/18

AABB Accepting Questions for "Ask the FDA & CMS/CLIA" Session at the 2018 Annual Meeting – 07/13/18

News Flash FDA Releases Revised Final Guidance on Zika Virus Testing – 07/06/18

REGULATORY UPDATE: FDA Issues Updated 2018 Guidance Agenda – 06/29/18

REGULATORY UPDATE: FDA Releases Draft Agenda and Materials for July 18-19 BPAC – 06/29/18

AABB Staff Members Attend 2018 CBER Science Symposium – 06/29/18

REGULATORY UPDATE: Electronic Version of the October 2017 Circular of Information – 06/22/18

REGULATORY UPDATE: AABB, ABC and ARC Submit Comments Supporting ZIKV NAT – 06/15/18

REGULATORY UPDATE: FDA Issues New BECS Final Rule – 05/25/18

REGULATORY UPDATE: FDA Announces BPAC Meetings and CBER Research Symposium – 05/25/18

REGULATORY UPDATE: FDA Approves Procleix Ultrio Elite Assay – 05/18/18

REGULATORY UPDATE: Ebola Outbreak Expands in Democratic Republic of the Congo – 05/18/18

REGULATORY UPDATE: FDA Withdraws Direct Final Rule – 05/11/18

REGULATORY UPDATE: CDC Updates Malaria Risk in Costa Rica – 05/11/18

Democratic Republic of the Congo Confirms New Ebola Outbreak – 05/11/18

REGULATORY UPDATE: CDC Confirms Resolution of Malaria Outbreaks in Costa Rica and Cape Verde – 04/20/18

REGULATORY UPDATE: AABB Posts Summary of FDA Liaison Committee Meeting - 04/13/18

Warnings Regarding Synthetic Marijuana Use by Plasma and Blood Donors - 04/13/18

REGULATORY UPDATE: CDC Updates Malaria Risk in South Africa - 03/30/18

REGULATORY UPDATE: Electronic Circular of Information - 03/16/18

REGULATORY UPDATE: FDA Approves First Tests to Screen Blood for Babesia - 03/09/18

REGULATORY UPDATE: FDA Announces Joint Advisory Committee Meeting - 03/02/18

REGULATORY UPDATE: FDA Approves Culture Bottle Options as Secondary "Safety Measure" Test - 03/02/18

REGULATORY UPDATE: FDA Updates Inspection Regulations – 02/02/18

REGULATORY UPDATE: CDC Updates Malaria Risk for Bahia State, Brazil – 02/02/18

FDA and DoD Launch Program to Expedite Availability of Medical Products for Military Use – 01/26/18

FDA Releases 2018 Strategic Policy Roadmap That Includes Blood and Cellular Therapies - 01/26/18

FDA Releases 2018 CBER Guidance Agenda - 01/26/18

CTMC Provides Recommendations to Address Nationwide Saline Shortage – 01/12/18

FDA Releases New and Updated Guidance Documents – 01/05/18