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… Real-World Data to Generate Real-World Evidence for Regulatory Safety Studies Thursday, June 20, 2024 8:00 AM to …
… utility measurement Internal stakeholder support clinical, regulatory, market access, or in-country collaboration …
… challenge. Eight independent modeling groups from the US and Europe, including researchers from RTI Health …
… assessment of PROs. Over the last five years, the US FDA has advocated for including patients’ voice in drug …
… framework, structured benefit-risk assessment, regulatory decisions, and decision making throughout the … the ISPOR FDA summit. She has over 50 peer-reviewed publications in journals that include The Patient, Value in …
… Around 0.5% of women in Europe and 2% of women in the US use antiepileptic drugs during pregnancy. It is important … and 3 that were similar enough to each other to enable us to conduct appropriate comparisons. This figure shows …
… by Naoko Ronquest (she/her), PhD, Executive Director, US HTA Strategy and Early Modeling and Kyle Paret , PhD, … older). The ratings represent how well the United States (US) trial population compares with the distribution observed … all stakeholders developing new treatments marketed in the US to: Consider publishing trial design and demographic …
… and are a major focus of ongoing drug development. The US Food and Drug Administration (FDA) strongly encourages the …
… BRCA1/2 Mutated Advanced Breast Cancer: Results From a US Retrospective Medical Records Review Study . Elias Obeid, …
… the trends and the lessons learned from this review of US product labeling will enable you to formulate better PRO …