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Publications by Benjamin Chacko

FDA Reported Use of Patient Experience Data in 2018 Drug Approvals

Therapeutic Innovation and Regulatory Science
PharmacologyPublic HealthEnvironmentalToxicologyPharmaceuticsOccupational Health
2019English

Related publications

2017 FDA Drug Approvals

Nature Reviews Drug Discovery
MedicineDrug DiscoveryPharmacology
2018English

FDA Town Hall: New Drug Approvals in Gastrointestinal Disease (2018-2019)

Gastroenterology
HepatologyGastroenterology
2020English

Patient-Reported Outcome Claims in European and United States Orphan Drug Approvals

Value in Health
MedicineHealth PolicyPublic HealthOccupational HealthEnvironmental
2018English

Patient-Reported Outcomes in Orphan Drug Labels Approved by the US FDA

Value in Health
MedicineHealth PolicyPublic HealthOccupational HealthEnvironmental
2019English

Correction To: FDA and EMA Biosimilar Approvals

Journal of General Internal Medicine
Internal Medicine
2019English

PCN119 Patient-Reported Outcomes (PROs) in Antineoplastic Product Approvals in Europe and in the USA

Value in Health
MedicineHealth PolicyPublic HealthOccupational HealthEnvironmental
2012English

Development of a Patient Reported Experience Measure (Prem) for Use in the Ambulance Service

Emergency Medicine Journal
MedicineCritical CareEmergency MedicineIntensive Care Medicine
2015English

Use of Patient-Reported Outcomes in the Context of Different Levels of Data*

Journal of Bone and Joint Surgery - Series A
MedicineSurgeryOrthopedicsSports MedicineSports Science
2011English

Beyond the FDA PRO Guidance: Steps Toward Integrating Meaningful Patient-Reported Outcomes Into Regulatory Trials and US Drug Labels

Value in Health
MedicineHealth PolicyPublic HealthOccupational HealthEnvironmental
2012English

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