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… with industry and government partners across a range of disease and therapy areas. Dr. Mellor has presented his …
… anesthesia in an operating room (OR). In November, the U.S. Food and Drug Administration (FDA) granted approval to Tusker Medical’s Tula System. The system will allow ENT physicians to insert ear tubes in an office setting using Tusker Medical’s TYMBION® local anesthesia system. To support the regulatory …
… of Value & Access, Europe RTI Health Solutions With the EU's developing guidelines designed to standardise and bring … include more large-molecule drugs or biologicals instead. Disease-Level Response Companies might be thinking of … Assessments and Joint Scientific Consultations: Let's All Work Together Joint Clinical Assessments: Racing to the …
… provides guidance on determining go/no go decisions, understanding potential threats to the validity of the …
Knowledgebase Infographics Our experts share their insights and key tips for successful projects in these easy-to-understand infographics. …
Effects of Continuous Use of Antidepressants on Dementia The effect of continuous use of antidepressants, with or without anticholinergic properties, for at least 4 months versus no treatment on the incidence of dementia: a target trial emulation. Forns …
… in conducting all aspects of the SLRs, from developing the search strategy through to report writing and critical appraisal. Mrs. Mitchell has experience in project … and courses run by the Cochrane Collaboration, ISPOR, the Critical Appraisal Skills Program, and other leading …
… include: Highlights and Overview Product Information and Disease Description Clinical Evidence Economic Information … which allow your chosen clinical expert to present key disease and unmet need evidence to US health care decision … focused materials to help you communicate your product’s key clinical and economic evidence to support your pricing, …
Longitudinal Modeling Approaches to Assess Association Between Two Clinical Outcomes Assessments Bintu Sherif, MS Director, Biostatistics Transcript With an increased regulatory focus on incorporating patient perspectives in drug development, …
… health records, claims and billing activities, product and disease registries, or health-monitoring devices) – this … and health literacy. The FDA may assess an instrument’s “fit-for-purpose” classification by considering the … will vary based on whether the instrument supports a study’s primary endpoint, inclusion criteria, or a safety outcome. …