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… Webinar: Characteristics of Recent PRO Labeling by the FDA and EMA for Oncology Drugs Share on: Wednesday, March 13 … PRO drug labeling who understand these differences can use that knowledge to guide their PRO measurement … labeling claims from both agencies. Learning objectives • What are the main characteristics of the labels granted by …
… have a conversation about their findings. They will cover what you need to know as you gather evidence about your … answer your questions about PRO labeling strategy. You’ll learn: Trends in PRO labeling over the past 10 years Types of … likely Examples of successes and failures, and the lessons we've learned Related Services Market Access and Outcomes …
… Regulatory Guidance and Support We can support you throughout your regulatory negotiations. Our team has negotiated with the FDA’s Clinical Outcome Assessments (COA) team and a wide …
… and scientific information about your products ahead of FDA approval can help improve patient access to emerging therapies and … unmet need, and early clinical data with stakeholders. We can also support your development of PIE webinars which …
… Recent FDA Drug and Device Guidelines for Sharing Pre-Approval … device has been approved or received clearance, payers can request a wide range of information from manufacturers. … is especially important for manufacturers developing what are expected to be high-cost treatment options in the …
… How Do We Get Drug Labeling Based on Patient Reported Outcomes? … of labeling, the important thing to realize is that - what is it that we want to say? What is it that you want to … What's the value proposition in simple language that can be understood by patients or other stakeholders as well. …
… tools to ensure your research findings and value messages can be adopted by the relevant audiences. To help communicate your product’s value, we can provide a wide range of deliverables including GVDs, … GVDs present evidence-based messages that demonstrate what your new product brings to the market and how it will be …
… registries presents both opportunities and limitations. We understand the issues and can help you determine if it is feasible and effective to use … for pharmaceutical clients at the request of the US FDA, EMA, and other national agencies in North America, …
… EMA Selects Research Collaboration to Prepare for Rapid … case series analyses of specific severe adverse events as well as for monitoring the effectiveness of … research to identify data sources and methods which can be used in future research that will monitor vaccine …
… FDA and AMCP Guidance on Pre-Approval Submissions and the … in advance of a product’s approval by the FDA so that they can make timely coverage and reimbursement decisions. The … indications and a copy of the most current FDA-required labeling As new information or updated versions of previously …