US FDA patient-reported outcome guidance: great expectations and unintended consequences.

Expert review of pharmacoeconomics & outcomes research

Volumn 13, Issue 4, 2013, Pages 441-446

  Fehnel, Sheri ^a   DeMuro, Carla ^b   McLeod, Lori ^b   Coon, Cheryl ^b   Gnanasakthy, Ari ^b  

^a RTI HEALTH SOLUTIONS   (United States)

^b NONE

Author keywords

[No Author keywords available]

Indexed keywords

ATTITUDE TO HEALTH; CLINICAL TRIAL (TOPIC); DRUG LABELING; EVIDENCE BASED MEDICINE; FOOD AND DRUG ADMINISTRATION; HEALTH CARE POLICY; HUMAN; INTERPERSONAL COMMUNICATION; LEGISLATION AND JURISPRUDENCE; PACKAGING; PATIENT EDUCATION; PATIENT PARTICIPATION; PRACTICE GUIDELINE; SELF REPORT; STANDARDS; UNITED STATES;

CLINICAL TRIALS AS TOPIC; COMMUNICATION; DRUG LABELING; EVIDENCE-BASED MEDICINE; GUIDELINE ADHERENCE; GUIDELINES AS TOPIC; HEALTH KNOWLEDGE, ATTITUDES, PRACTICE; HEALTH POLICY; HUMANS; PATIENT EDUCATION AS TOPIC; PATIENT PARTICIPATION; PRODUCT LABELING; SELF REPORT; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84893020044     PISSN: None     EISSN: 17448379     Source Type: Journal    
DOI: 10.1586/14737167.2013.814957     Document Type: Review

References (0)