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Cohort study of all trials conducted for Pediatric Exclusivity, the subsequent labeling changes, and the publication of those studies in peer-reviewed journals. We categorized each study in the exclusivity application as ”successful” or “unsuccessful” based on FDA approval of the indication sought by the sponsor. We categorized any labeling changes resulting from the studies as ”positive” or “negative” for the drug under study. We then evaluated aspects of the studies and product label changes that were associated with subsequent publication in peer-reviewed medical journals.
Research Article: Journal of Clinical Trials
Research Article: Journal of Clinical Trials
Research Article: Journal of Clinical Trials
Research Article: Journal of Clinical Trials
Editorial: Journal of Clinical Trials
Scientific Tracks Abstracts: Journal of Clinical and Cellular Immunology
Scientific Tracks Abstracts: Clinical & Experimental Cardiology
Scientific Tracks Abstracts: Clinical & Experimental Cardiology
Investigation into the effect of pH and temperature on the survival of Salmonella enterica serovar typhimurium
Scientific Tracks Abstracts: Journal of Nutrition & Food Sciences