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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 …
… 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 …
… 2020 FDA Patient-Reported Outcomes Guidance Draft On August 31, 2020, the FDA released its draft guidance titled “Principles for … The agency encourages modifying and adapting existing PRO instruments, where feasible, rather than creating new …
… New FDA Draft Guidance For Evaluating Patient-Reported Outcomes … Share on: September 3, 2020 On August 31, 2020, the FDA released its draft guidance titled “Principles for … The agency encourages modifying and adapting existing PRO instruments, where feasible, rather than creating new …
… New System for Ear Tube Insertion Approved by FDA: General Anesthesia Not Required Share on: January 7, … (OR). In November, the U.S. Food and Drug Administration (FDA) granted approval to Tusker Medical’s Tula System. The … rewarding to work on studies like this that support the FDA regulatory process and advance patient care.” Related …
… FDA Rare Disease Day 2024 Virtual Public Meeting Share on: … at RTI Health Solutions, will be presenting at the US FDA’s Virtual Public Meeting in recognition of Rare Disease … surrounding patient committee participants on the FDA-sponsored study to adapt an in-clinic outcome assessment …
… Recent FDA Drug and Device Guidelines for Sharing Pre-Approval … far in advance of approval decisions. As a result, the FDA has now released guidance to help manufacturers share … communication channel that hasn’t existed before. For help understanding how to develop effective and appropriate …
… FDA’s Sentinel Initiative Driving Sound Research Practices … on: November 11, 2021 RTI-HS is collaborating with the FDA to ensure that rigorous, valid methods are used to … RTI-HS, shares, “We are honored to be working with the FDA and their network of research collaborators committed to …