Impact of pediatric exclusivity on drug labeling and demonstrations of efficacy

Pediatrics

Volumn 134, Issue 2, 2014, Pages

  Wharton, Gerold T ^a   Murphy, M Dianne ^a   Avant, Debbie ^a   Goldsmith, John V ^a   Chai, Grace ^a,b   Rodriguez, William J ^a   Eisenstein, Eric L ^c  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

^b DUKE UNIVERSITY   (United States)

^c DUKE CLINICAL RESEARCH INSTITUTE   (United States)

Author keywords

Blockbuster drug; Cancer oncology; Clinical trials; Drug safety; Drug sales; Efficacy; FDA; Gastrointestinal; Labeling changes; Moiety; Negative studies; Pediatric exclusivity

Indexed keywords

ANAGRELIDE; ANALGESIC AGENT; ANESTHETIC AGENT; ANTINEOPLASTIC AGENT; CARDIOVASCULAR AGENT; DESFLURANE; GASTROINTESTINAL AGENT; HORMONES AND AGENTS ACTING ON THE ENDOCRINE SYSTEM; MOMETASONE FUROATE;

ARTICLE; DRUG APPROVAL; DRUG EFFICACY; DRUG INDICATION; DRUG LABELING; DRUG MARKETING; DRUG RESEARCH; DRUG SAFETY; PRIORITY JOURNAL; UNITED STATES;

BLOCKBUSTER DRUG; CANCER/ONCOLOGY; CLINICAL TRIALS; DRUG SAFETY; DRUG SALES; EFFICACY; FDA; GASTROINTESTINAL; LABELING CHANGES; MOIETY; NEGATIVE STUDIES; PEDIATRIC EXCLUSIVITY;

CLINICAL TRIALS AS TOPIC; DRUG APPROVAL; DRUG INDUSTRY; DRUG LABELING; DRUG THERAPY; HUMANS; MARKETING; PATIENT SELECTION; RESEARCH SUBJECTS; TREATMENT OUTCOME; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84905270591     PISSN: 00314005     EISSN: 10984275     Source Type: Journal    
DOI: 10.1542/peds.2013-2987     Document Type: Article

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