Assessment of risk of variant creutzfeldt‐Jakob disease (vCJD) from use of bovine heparin-Reference-Cited by-同舟云学术

Assessment of risk of variant creutzfeldt‐Jakob disease (vCJD) from use of bovine heparin

Published:2020-03-05 Issue:5 Volume:29 Page:575-581
ISSN:1053-8569
Container-title:Pharmacoepidemiology and Drug Safety
language:en
Short-container-title:Pharmacoepidemiol Drug Saf

Author:

Huang Yin¹^ORCID,Forshee Richard A.¹,Keire David²,Lee Sau²,Gregori Luisa³,Asher David M.³,Bett Cyrus³,Niland Brian⁴,Brubaker Scott A.⁴,Anderson Steven A.¹,Yang Hong¹

Affiliation:

1. FDA Center for Biologics Evaluation and ResearchOffice of Biostatistics and Epidemiology Silver Spring Maryland

2. FDA Center for Drug Evaluation and ResearchOffice of Pharmaceutical Quality Silver Spring Maryland

3. FDA Center for Biologics Evaluation and ResearchOffice of Blood Research and Review Silver Spring Maryland

4. FDA Center for Biologics Evaluation and ResearchOffice of Tissues and Advanced Therapies Silver Spring Maryland

Publisher

Wiley

Subject

Pharmacology (medical),Epidemiology

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/pds.4982

Reference31 articles.

1. FDA. FDA encourages reintroduction of bovine‐sourced heparin.2018.https://www.fda.gov/Drugs/DevelopmentApprovalProcess/Manufacturing/ucm600976.htm. Accessed November 5 2018.

2. Characterization of currently marketed heparin products: key tests for quality assurance

3. The US regulatory and pharmacopeia response to the global heparin contamination crisis

4. Heparin crisis 2008: a tipping point for increased FDA enforcement in the pharma sector?;Rosania L;Food Drug Law J,2010

5. FDA. Information on adverse event reports and heparin.https://wayback.archive‐it.org/7993/20170723181527/https://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/UCM112669. Accessed November 5 2018.

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3. Eliminating Spiked Bovine Spongiform Encephalopathy Agent Activity from Heparin;Emerging Infectious Diseases;2020-10

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