USA Archives - rwr-regs

USA | FDA Draft Guidance on Sex Differences Reinforces Expectations for Non-Interventional Studies
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USA | FDA Draft Guidance on Sex Differences Reinforces Expectations for Non-Interventional Studies

2025, December 2025, Members-Only, Moderate Update, USA

USA | FDA Draft Guidance on Sex Differences Reinforces Expectations for Non-Interventional Studies

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USA | FDA Draft Guidance on Sex Differences Reinforces Expectations for Non-Interventional Studiesstuart.mccully2026-01-09T14:18:59+00:00

USA | FDA Removes Requirement for Identifiable Patient Data in Certain Medical Device RWE Submissions – Signals Potential Extension to Drugs and Biologics
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USA | FDA Removes Requirement for Identifiable Patient Data in Certain Medical Device RWE Submissions – Signals Potential Extension to Drugs and Biologics

2025, December 2025, Members-Only, Moderate Update, RWD to Support Reg Decisions, Secondary Use of Existing Data, USA

USA | FDA Removes Requirement for Identifiable Patient Data in Certain Medical Device RWE Submissions – Signals Potential Extension to Drugs and Biologics

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USA | FDA Removes Requirement for Identifiable Patient Data in Certain Medical Device RWE Submissions – Signals Potential Extension to Drugs and Biologicsstuart.mccully2026-01-09T14:13:46+00:00

USA | FDA Issues Updated Final Guidance on Use of Real-World Evidence for Medical Devices
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USA | FDA Issues Updated Final Guidance on Use of Real-World Evidence for Medical Devices

2025, December 2025, Medical Devices, Members-Only, RWD to Support Reg Decisions, USA

USA | FDA Issues Updated Final Guidance on Use of Real-World Evidence for Medical Devices

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USA | FDA Issues Updated Final Guidance on Use of Real-World Evidence for Medical Devicesstuart.mccully2026-01-09T12:42:07+00:00

USA | E-Prescribing and Interoperability Rules Strengthen Foundations for Real-World Evidence
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USA | E-Prescribing and Interoperability Rules Strengthen Foundations for Real-World Evidence

2025, August 2025, Members-Only, Minor Update, Secondary Use of Existing Data, USA

USA | E-Prescribing and Interoperability Rules Strengthen Foundations for Real-World Evidence

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USA | E-Prescribing and Interoperability Rules Strengthen Foundations for Real-World Evidencestuart.mccully2025-09-10T11:08:19+00:00

USA | FDA’s CDER Reports RWE Submission Trends
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USA | FDA’s CDER Reports RWE Submission Trends

2025, August 2025, Members-Only, Minor Update, RWD to Support Reg Decisions, Secondary Use of Existing Data, USA

USA | FDA’s CDER Reports RWE Submission Trends

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USA | FDA’s CDER Reports RWE Submission Trendsstuart.mccully2025-09-10T11:03:13+00:00

USA | FDA-NIH Collaboration Establishes RWE Definitions for Modern Clinical Research
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USA | FDA-NIH Collaboration Establishes RWE Definitions for Modern Clinical Research

2025, June 2025, Members-Only, Minor Update, USA

USA | FDA-NIH Collaboration Establishes RWE Definitions for Modern Clinical Research

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USA | FDA-NIH Collaboration Establishes RWE Definitions for Modern Clinical Researchstuart.mccully2025-07-08T15:16:54+00:00

USA | Study of Sex Differences in the Clinical Evaluation of Medical Products
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USA | Study of Sex Differences in the Clinical Evaluation of Medical Products

2025, January 2025, Members-Only, Moderate Update, USA

USA | Study of Sex Differences in the Clinical Evaluation of Medical Products

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USA | Study of Sex Differences in the Clinical Evaluation of Medical Productsstuart.mccully2025-02-06T11:32:07+00:00

USA | Draft FDA Guidance on Protocol Deviations for Clinical Investigations of Drugs, Biologics, and Devices
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USA | Draft FDA Guidance on Protocol Deviations for Clinical Investigations of Drugs, Biologics, and Devices

2024, December 2024, Members-Only, USA

USA | Draft FDA Guidance on Protocol Deviations for Clinical Investigations of Drugs, Biologics, and Devices

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USA | Draft FDA Guidance on Protocol Deviations for Clinical Investigations of Drugs, Biologics, and Devicesstuart.mccully2025-01-02T18:04:03+00:00

USA | Draft FDA Guidance – Integrating Randomized Controlled Trials for Drug and Biological Products Into Routine Clinical Practice
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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

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USA | Draft FDA Guidance – Integrating Randomized Controlled Trials for Drug and Biological Products Into Routine Clinical Practicestuart.mccully2024-10-06T14:58:52+00:00

USA | RAISE Action Framework to Improve Race and Ethnicity Data Collection in Health Care
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USA | RAISE Action Framework to Improve Race and Ethnicity Data Collection in Health Care

2024, August 2024, Diversity, Members-Only, Minor Update, USA

USA | RAISE Action Framework to Improve Race and Ethnicity Data Collection in Health Care

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USA | RAISE Action Framework to Improve Race and Ethnicity Data Collection in Health Carestuart.mccully2024-09-01T11:32:40+00:00

USA | FDA Draft Guidance on Sex Differences Reinforces Expectations for Non-Interventional Studies

USA | FDA Removes Requirement for Identifiable Patient Data in Certain Medical Device RWE Submissions – Signals Potential Extension to Drugs and Biologics

USA | FDA Issues Updated Final Guidance on Use of Real-World Evidence for Medical Devices

USA | E-Prescribing and Interoperability Rules Strengthen Foundations for Real-World Evidence

USA | FDA’s CDER Reports RWE Submission Trends

USA | FDA-NIH Collaboration Establishes RWE Definitions for Modern Clinical Research

USA | Study of Sex Differences in the Clinical Evaluation of Medical Products

USA | Draft FDA Guidance on Protocol Deviations for Clinical Investigations of Drugs, Biologics, and Devices

USA | Draft FDA Guidance – Integrating Randomized Controlled Trials for Drug and Biological Products Into Routine Clinical Practice

USA | RAISE Action Framework to Improve Race and Ethnicity Data Collection in Health Care

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