Message to the FDA on ESAs: REMS is not enough, more studies are needed.
Singh
Ajay K
AK
D002908:Chronic Disease; D002983:Clinical Competence; D017277:Drug Approval; D019317:Evidence-Based Medicine; D007722:Health Knowledge, Attitudes, Practice; D006397:Hematinics / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D007674:Kidney Diseases / Q000097:blood / Q000628:therapy*; D010353:Patient Education as Topic; D018579:Patient Selection; D010818:Practice Patterns, Physicians'; D006435:Renal Dialysis / Q000009:adverse effects; D018570:Risk Assessment; D012307:Risk Factors; D016896:Treatment Outcome; D014481:United States
D006397:Hematinics