Mandatory comparator trials for therapeutically similar drugs: an assessment of the facts.
Milne
Christopher-Paul
CP
Tufts Center for the Study of Drug Development, Tufts University, Boston, MA 02111, USA. christopher.milner@tufts.edu
Kaitin
Kenneth I
KI
Dimasi
Joseph A
JA
D002986:Clinical Trials as Topic / Q000191:economics / Q000331:legislation & jurisprudence*; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D006801:Humans; D007880:Legislation, Drug; D018570:Risk Assessment; D013810:Therapeutic Equivalency; D014481:United States