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… capmatinib, which gained accelerated approval from the US FDA in 2020. To provide context to the results, effectiveness outcomes in capmatinib patients were … for this real-world study were collected from across the US, via a retrospective medical record review, and captured …
… Committee. Version 5.0 (PBAC, 2016) Belgium Belgian Health Care Knowledge Centre EQ-5D (recommended or preferred MAUI). … commonly used, it allows the greatest comparability of the results of economic analyses.” Health Technology Assessment … or preferred MAUI). Preferences from Latino population in US should be used. Manual Para la Elaboración de Evaluaciones …
… with these guidelines will be mandatory 180 days after the final guidance is published for clinical trials … prevalence of the condition in the intended United States (US) population. This poses significant challenges for study … will need to be evaluated within the fiercely competitive landscape of pharmaceutical research. Overall, the FDA …
RTI Health Solutions Joins MDIC Collaborative Share on: October 18, 2016 RTI Health Solutions Joins Collaborative to Include Patient Risk Preference in Clinical Trials RESEARCH TRIANGLE PARK, NC – (October 18, 2016) – RTI Health Solutions , a business …
… with vast experience leading studies using existing health care data to evaluate the use, safety, and effectiveness of … in the field of pharmacoepidemiology. His experience and publications span a wide range of substantive areas, … public health audiences about observational study design, large database utilization, and propensity score analysis. …
… in evaluating the value of health technologies in the US. In a recent study, the majority of payers interviewed … However, despite the growing influence of ICER in the US, best practices for engaging with ICER have not been …
… Event: August 6, 2024 | 12:00 EDT The Academy of Managed Care Pharmacy (AMCP) dossier Format for Formulary Submissions … seeking reimbursement and/or formulary placement in the US for new pharmaceuticals, biologics, and vaccines. …
… information that is required by a broad range of health care decision makers, which is crucial for avoiding delays on … our extensive experience in understanding the global payer landscape to better align the value your products deliver …
Navigating EU Joint Clinical Assessments and Joint Scientific Consultations From January 2025 Onward
… JCAs remain to be reconfirmed in the final Implementation Act, which completed public consultation in April 2023. We … smaller, heterogeneous populations where the standard of care across the EU might vary considerably. Joint clinical … in the European Union and the Inflation Reduction Act in the United States …
… requirements. Being ready to move forward expediently after regulatory approval means you need to fully explore … product has received fast-track designation, like the US FDA’s Regenerative Medicine Advanced Therapies (RMAT) or … market entry for your product as quickly as possible after regulatory approval. A Wealth of Experience We have …