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… Webinar: Characteristics of Recent PRO Labeling by the FDA and EMA for Oncology Drugs Share on: …
… RTI-HS Webinar - Lessons Learned From a Review of FDA PRO Labeling Share on: December 12, 2016 Image Click to view …
… regulatory negotiations. Our team has negotiated with the FDA’s Clinical Outcome Assessments (COA) team and a wide … acceptable to the FDA following the release of the FDA’s PRO Guidance. To support these efforts, we have developed … clients to FDA meetings in support of their proposed labeling claims. Our experts, particularly those based in …
… Recent FDA Drug and Device Guidelines for Sharing Pre-Approval … of results from studies, including clinical studies of drugs or devices or bench tests that describe device … potency, or “drug of choice” should be avoided) The recent FDA guidance opens up a communication channel that …
… prevalence and public health impact Event rates Patient characteristics Treatment patterns and drug utilization … for pharmaceutical clients at the request of the US FDA, EMA, and other national agencies in North America, Europe, …
… Webinar: Common Challenges & Solutions in Analysis of PROs in Oncology Clinical Trials Share on: Wednesday, March 21, … analyzing, and interpreting patient-reported outcome (PRO) data for oncology trials can present unique challenges. …
… Webinar: Advanced Network Meta-analysis Share on: Thursday, … and how they are received by regulatory agencies such as FDA and EMA. Join us as our panel of experts discusses some of the recent developments in Bayesian analysis. You’ll learn: How …
… Webinar: Strategic Planning for Orphan Drugs Share on: Tuesday, June 7, 2022, 10 - 11am Maximizing … markets and how to plan for gaining access to them This webinar is ideal for those who wish to leverage evidence …
… Thirteenth Annual FDA Sentinel Initiative Public Workshop Share on: Monday, … for Health Policy under a cooperative agreement with the FDA. Dr. Layton will be joining Session VI: BEST Collaborator … of the Sentinel community and leading experts to share recent developments within the Sentinel Initiative , provide …
… Trends in the Inclusion of Patient Reported Outcomes in Oncology Clinical Trials Margaret Mordin, MS Vice President, … the number of trials that use a patient reported outcome (PRO) measure, particularly in oncology trials. They reported … assessment of PROs. Over the last five years, the US FDA has advocated for including patients’ voice in drug …