A review of FDA warning letters and notices of violation issued for patient-reported outcomes promotional claims between 2006 and 2012

Value in Health

Volumn 17, Issue 4, 2014, Pages 433-437

  Symonds, Tara ^a   Hackford, Claire ^a   Abraham, Lucy ^a  

^a Patient Reported Outcomes Center of Excellence Global Market Access Primary Care   (United Kingdom)

Author keywords

Food and Drug Administration; patient reported outcome; PRO Guidance; promotional claim

Indexed keywords

PRESCRIPTION DRUG;

CLINICAL TRIAL (TOPIC); CONTENT VALIDITY; DRUG INDUSTRY; DRUG MARKETING; FOOD AND DRUG ADMINISTRATION; FREEDOM OF INFORMATION ACT; HUMAN; NOTICES OF VIOLATION; OUTCOMES RESEARCH; PATIENT REPORTED OUTCOME; PRIORITY JOURNAL; REVIEW; SOCIAL PROBLEM; STATISTICAL ANALYSIS; STUDY DESIGN; WARNING LETTER;

FOOD AND DRUG ADMINISTRATION; PATIENT-REPORTED OUTCOME; PRO GUIDANCE; PROMOTIONAL CLAIM;

ADVERTISING AS TOPIC; CORRESPONDENCE AS TOPIC; DRUG INDUSTRY; ECONOMICS, PHARMACEUTICAL; FRAUD; GOVERNMENT REGULATION; HUMANS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84903127144     PISSN: 10983015     EISSN: 15244733     Source Type: Journal    
DOI: 10.1016/j.jval.2014.03.1718     Document Type: Article

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