Message to the FDA on ESAs: REMS Is Not Enough, More Studies Are Needed

Author:

Singh Ajay K.

Publisher

American Society of Nephrology (ASN)

Subject

Transplantation,Nephrology,Critical Care and Intensive Care Medicine,Epidemiology

Reference26 articles.

1. US Food and Drug Administration: FDA drug safety communication: Erythropoiesis-stimulating agents (ESAs)—Procrit, Epogen and Aranesp. Available at: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm200297.htm . Accessed April 20, 2010

2. ESA APPRISE Oncology Program. Available at: https://www.esa-apprise.com/ESAAppriseUI/ESAAppriseUI/default.jsp . Accessed April 20, 2010

3. Southern California Renal Disease Council: FDA: Drug safety communication—Erythropoiesis-stimulating agents (ESAs): Procrit, Epogen and Aranesp. Available at: http://www.esrdnetwork18.org/pdfs/QI%20-%20FDA%20Recall/2010%20FDA%20Recalls/Drug_Safety_Communication_021710.pdf . Accessed April 20, 2010

4. ESA APPRISE Oncology Program: ESA APPRISE Oncology Program Patient and Healthcare Professional (HCP) Acknowledgment Form (Acknowledgment Form). Available at: http://www.abgenix.com/pdfs/products/Patient_HCP_Acknowedgment_form.pdf . Accessed April 20, 2010

5. Food and Drug Administration Amendments Act of 2007. Available at: http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=110_cong_public_laws&docid=f:publ085.110 . Accessed April 20, 2010

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