- USA | Draft FDA Guidance – Integrating Randomized Controlled Trials for Drug and Biological Products Into Routine Clinical Practice Gallery
USA | Draft FDA Guidance – Integrating Randomized Controlled Trials for Drug and Biological Products Into Routine Clinical Practice
2024, Members-Only, Minor Update, RWD to Support Reg Decisions, Secondary Use of Existing Data, September 2024, USA
USA | Draft FDA Guidance – Integrating Randomized Controlled Trials for Drug and Biological Products Into Routine Clinical Practice
Please login to view this page.
USA | FDA Finalises EHR and Medical Claims Real World Data Guidance
Please login to view this page.
USA | Draft FDA Non-Interventional Study Guidance
Please login to view this page.
USA | Draft FDA Guidance: Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices
Please login to view this page.
USA | FDA Finalises Rare Diseases Considerations Guidance
Please login to view this page.
- USA | FDA Finalises RWD Guidance on Assessing Registries To Support Regulatory Decision-Making for Drug and Biological Products Gallery
USA | FDA Finalises RWD Guidance on Assessing Registries To Support Regulatory Decision-Making for Drug and Biological Products
December 2023, Members-Only, Moderate Update, RWD to Support Reg Decisions, Secondary Use of Existing Data, USA
USA | FDA Finalises RWD Guidance on Assessing Registries To Support Regulatory Decision-Making for Drug and Biological Products
Please login to view this page.
USA | FDA Finalises Guidance on “Data Standards for Drug and Biological Product Submissions Containing Real-World Data
Please login to view this page.
- USA | Draft FDA Guidance – Postmarketing Approaches to Obtain Data on Populations Underrepresented in Clinical Trials for Drugs and Biological Products Gallery
USA | Draft FDA Guidance – Postmarketing Approaches to Obtain Data on Populations Underrepresented in Clinical Trials for Drugs and Biological Products
USA | Draft FDA Guidance – Postmarketing Approaches to Obtain Data on Populations Underrepresented in Clinical Trials for Drugs and Biological Products
Please login to view this page.
USA | Final FDA RWE Considerations Guidance Published
Please login to view this page.