OBJECTIVES: To perform a systematic literature review of pharmacoeconomic (PE) publications considering recent United States (US) Food and Drug Administration (FDA) new molecular entity and new biologic license approvals (NMEs/NBLs).  The review investigated publication quality and US relevance. METHODS: MEDLINE and the United Kingdom National Health Service Economic Evaluation Database were searched.  Included publications considered 2008-2009 NMEs/NBLs in original PE evaluations.  In addition to general characteristics, each publication was evaluated using the Quality of Health Economic Studies (QHES) Instrument.  The correlation between QHES scores and the 2010 Thomson Reuters five-year journal Impact Factor (IF-5y) was calculated.  Median QHES score differences were compared (Mann-Whitney U) by study characteristics (yes/no): US context, academic first author, pharmaceutical manufacturer funding (PMF), and declared author independence. RESULTS: From 115 unique search results, 31 met inclusion criteria.  Of fifty 2008-2009 NMEs/NBLs, 36% had PE publications, with 81% considering the approval indication and 61% published post-approval.  A US context was assessed in 35% of publications.  PMF was present in 68% of publications, comprising manufacturers marketing either the NME/NBL, 90%, or a comparator, 10%.  Time (mean±standard deviation (S.D.)) since FDA approval was 21.9±8.8 months until ePublication and 15.3±9.0 months until journal submission.  Median and mean±S.D. QHES score were 78 and 73.3±16.4, respectively.  Publications most often satisfied QHES items regarding uncertainty (5) and incremental analysis (6) (94% each).  Justifiying the chosen model (13) and discussing biases (14) were satisfied least often (38% each).  The IF-5y (mean= 3.46, S.D.= 3.37) was not  correlated with QHES score (Pearson r=0.095, p=0.636).  QHES scores were not-significantly different (p>0.05) for any study characteristics. CONCLUSIONS: QHES scores indicate PE studies of recent NMEs/NBLs are high quality, although US relevance is imperfect: few publications assessed a US context; some did not consider the approval indication; publication lags delay PE evidence availability; and most publications have PMF.