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… regular basis in order to remain up-to-date on the latest news regarding AMCP dossiers. …
Recent FDA Drug and Device Guidelines for Sharing Pre-Approval Information Share on: July 17, 2018 Communication of Pre-approval Information by Drug and Device Manufacturers to Payers in the US In the US, once a drug or medical device has been approved …
Using RTI Rarity™ to Support Clinical Trial Diversity Requirements Local Social Inequity Score Offers Precise Analysis of Social Risk Data The US Food and Drug Administration (FDA) recently released guidance that outlines specific diversity requirements …
2020 FDA Patient-Reported Outcomes Guidance Draft On August 31, 2020, the FDA released its draft guidance titled “Principles for Selecting, Developing, Modifying, and Adapting Patient-Reported Outcome Instruments for Use in Medical Device Evaluation.” …
New FDA Draft Guidance For Evaluating Patient-Reported Outcomes in Clinical Trials Share on: September 3, 2020 On August 31, 2020, the FDA released its draft guidance titled “Principles for Selecting, Developing, Modifying, and Adapting Patient-Reported …
… editor. She began her career as a health reporter for The News & Observer in Raleigh, NC, and other publications, where …
CHEERS 2022: A Conversation With Jo Mauskopf on Updated Standards for Health Economic Evaluation Reporting Share on: March 1, 2022 Guidance Expanded to Reflect Developments in Reporting Economic Evaluations of Health Interventions As part of …
FDA Draft Guidance: Crucial Advancement Toward More Inclusive Clinical Trials Share on: July 15, 2024 Contributed by: Ari Gnanasakthy, MBA, MSc Principal Scientist, Patient-Centered Outcomes Assessment RTI Health Solutions Almost 40% of the American …
FORTEO® Post-Market Osteosarcoma Surveillance Program: Real-World Data Contributes to Label Change Share on: January 25, 2021 The US Food and Drug Administration (FDA) is no longer requiring a black box warning on the label for the drug FORTEO® …
FDA and AMCP Guidance on Pre-Approval Submissions and the Continuous Process of Dossier Development Share on: December 20, 2019 Article contributed by: Shahnaz Khan, MPH , Executive Director, Market Access and Outcomes Strategy at RTI Health Solutions …