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… FDA Draft Guidance: Crucial Advancement Toward More Inclusive … in clinical trials, the Food and Drug Administration (FDA) recently released draft guidance that introduces the use … for submitting DAPs to the FDA and describes how sponsors can receive feedback from the agency. Sponsors must include …
… who have hundreds of combined years of applied experience, we can provide you with reliable, informed, and expert … we provide consulting support for specific projects or can set up long-term arrangements that allow access to …
… What New Practical Realities Will Joint Clinical Assessments … are looking to understand the potential implications of what will emerge when the guidelines have been finalised. … populations more tenable. Individual Drugs in Development We will see changes in strategy, particularly for phase 2b or …
… rare disease products, demonstrating value for therapies can be a challenge. The limited amount of data available … diseases? How do HTA bodies appraise rare disease drugs? What are the key challenges to developing cost-effectiveness models? How do we overcome these HTA economic modelling challenges? …
… industry responding to these new practical realities? We see companies responding on several levels. On the … client’s own teams to merge their expertise with ours. We can help develop IRA and EU HTA regulation impact analyses, … which development programs might be affected and in what ways, and formulate actionable recommendations to inform …
… Discovering What Treatment Options are Most Important to Patients With … it comes to treatment outcomes." The results of this study can help drug developers know where to focus their research. … providers. This study was sponsored by AbbVie. To learn more about the methods used in this study and view …
… Industry Responding to These New Practical Realities? We see companies responding on several levels. On the … clients' own teams to merge their expertise with ours. We can help develop IRA and EU HTAR impact analyses, anticipate … which development programs might be affected and in what ways, and formulate actionable recommendations to inform …
… PRO Analysis Portfolio Across Multiple Cancers OPPORTUNITY … of data while adhering to project deadlines. Additionally, we needed to account for differences in reporting … the result. Analyses included: Descriptive analyses of PRO questionnaire completion rates and score changes over …
… is the time for drug manufacturers to do everything they can to get ready for a potential submission in support of … chances that their product might be selected, determine what evidence Centers for Medicare and Medicaid Services (CMS) will most likely require, and learn how that evidence will be prioritized. The goal of the …
… in research. Read the other two articles here. Part 1: What Factors Influence Health Equity - or Inequity? Part 3: … of study results. In a previous article , we looked at a variety of factors affecting health equity and … Additionally, closing the gap on health inequities can enable biomedical and pharmaceutical companies to address …