| scholarly article | Q13442814 |
| systematic review | Q1504425 |
| review article | Q7318358 |
| P50 | author | Aaron S Kesselheim | Q50786389 |
| P2093 | author name string | Bo Wang | |
| P2860 | cites work | The impact of incremental innovation in biopharmaceuticals: drug utilisation in original and supplemental indications | Q86076165 |
| Electronic Health Data for Postmarket Surveillance: A Vision Not Realized. | Q30961413 | ||
| Rheumatoid arthritis disease activity measures: American College of Rheumatology recommendations for use in clinical practice | Q33637603 | ||
| Availability of comparative efficacy data at the time of drug approval in the United States | Q33888863 | ||
| Clinical trial evidence supporting FDA approval of novel therapeutic agents, 2005-2012. | Q34089761 | ||
| Characteristics of clinical trials to support approval of orphan vs nonorphan drugs for cancer | Q34189974 | ||
| Developmental pharmacology--drug disposition, action, and therapy in infants and children | Q34247047 | ||
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| Economic return of clinical trials performed under the pediatric exclusivity program | Q37412752 | ||
| New indications for already-approved drugs: an analysis of regulatory review times | Q37701423 | ||
| Innovating by developing new uses of already-approved drugs: trends in the marketing approval of supplemental indications | Q38111059 | ||
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| P275 | copyright license | Creative Commons Attribution-NonCommercial 4.0 International | Q34179348 |
| P407 | language of work or name | English | Q1860 |
| P921 | main subject | United States of America | Q30 |
| systematic review | Q1504425 | ||
| biomedical investigative technique | Q66648976 | ||
| supporting evidence | Q110632057 | ||
| drug approval | Q42214612 | ||
| pharmaceutical preparation | Q66089252 | ||
| P304 | page(s) | h4679 | |
| P577 | publication date | 2015-09-23 | |
| P1433 | published in | The BMJ | Q546003 |
| P1476 | title | Characteristics of efficacy evidence supporting approval of supplemental indications for prescription drugs in United States, 2005-14: systematic review | |
| P478 | volume | 351 |
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| Q93211087 | Completion Rate and Reporting of Mandatory Pediatric Postmarketing Studies Under the US Pediatric Research Equity Act |
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| Q90564383 | Generating comparative evidence on new drugs and devices after approval |
| Q90198829 | Nonrandomized Real-World Evidence to Support Regulatory Decision Making: Process for a Randomized Trial Replication Project |
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| Q58718992 | The Comparative Effectiveness of Innovative Treatments for Cancer (CEIT-Cancer) project: Rationale and design of the database and the collection of evidence available at approval of novel drugs |
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| Q50597191 | Timing and Characteristics of Cumulative Evidence Available on Novel Therapeutic Agents Receiving Food and Drug Administration Accelerated Approval. |
| Q92206554 | Timing of Pediatric Drug Approval and Clinical Evidence Submitted to Regulatory Authorities: International Comparison Among Japan, the United States, and the European Union |
| Q47438084 | Use of Health Care Databases to Support Supplemental Indications of Approved Medications |
| Q57288227 | Weighing of evidence by health technology assessment bodies: retrospective study of reimbursement recommendations for conditionally approved drugs |
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