Insights | Specializing in RWE

Register Now for Friends of Cancer Research Enhancing Diversity in Clinical Trials: Implementation of Diversity Plans

In: diversity, FOCR

February, 2024

FDA Releases Final Guidance on Rare Diseases: Considerations for the Development of Drugs and Biological Products

In: regulatory guidance, rare diseases, natural history, FDA

December, 2023

FDA Releases Final Guidance on Development of Monoclonal Antibody Products Targeting SARS-CoV-2 for Emergency Use Authorization

In: regulatory guidance, COVID-19, FDA

December, 2023

FDA Releases Final Guidance on Data Standards for Drug and Biological Product Submissions Containing Real-World Data

In: regulatory guidance, FDA

December, 2023

FDA Releases Final Guidance on Real-World Data: Assessing Registries to Support Regulatory Decision-Making for Drug and Biological Products

In: regulatory guidance, FDA

December, 2023

FDA Releases New Guidance on Postmarketing Approaches to Obtaine Data on Populations Underrepresented in Clinical Trials for Drugs and Biological Products

In: regulatory guidance, FDA

August, 2023

Reagan-Udall Foundation Real-World Data Webinars

In: data webinars

April, 2023

Watch Reagan-Udall's webinar on ECAs

In: data webinars, regulatory guidance, ECA

April, 2023

FDA Releases New Draft Guidance on Externally Controlled Trials (ECTs)

In: FDA, regulatory guidance, ECA

February, 2023