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ICH M14 Guideline: General Principles on Plan, Design and Analysis of Pharmacoepidemiological Studies That Utilize Real-World Data for Safety Assessment of Medicines

May 31
2 min

ICH M14 Guideline: General Principles on Plan, Design and Analysis of Pharmacoepidemiological Studies That Utilize Real-World Data for Safety Assessment of Medicines

Recently the International Council for Harmonisation (ICH) announced on 24 May, 2024 the availability of draft guidance for the industry...

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EMA Guidance: Real-World Evidence for supporting Regulatory Decision-Making

Sharan Murugan

Apr 16
2 min

EMA Guidance: Real-World Evidence for supporting Regulatory Decision-Making

On 12 April 2024 the European Medicines Agency released "Guidance on real-world evidence provided by EMA: support for regulatory...

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USFDA MD Guidance: Use of RWE to Support Regulatory Decision-Making forMedical Devices

Sharan Murugan

Dec 19, 2023
2 min

USFDA MD Guidance: Use of RWE to Support Regulatory Decision-Making forMedical Devices

Recently (14 December 2023) the U.S. Food and Drug Administration (FDA) Center for Biologics Evaluation and Research Center for Devices...

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USFDA Guidance: Submitting Documents Using Real-World Data & RW Evidence for Drug & Biologics

Sharan Murugan

Sep 8, 2022
1 min

USFDA Guidance: Submitting Documents Using Real-World Data & RW Evidence for Drug & Biologics

Earlier today (08-September-2022) USFDA's Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research...

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Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making

Sharan Murugan

Dec 11, 2021
2 min

Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making

Real-World Data (RWD) are data relating to patient health status and/or the delivery of health care routinely collected from a variety of...

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Data Standards for Drug & Biological Product Submissions Containing Real-World Data - USFDA

Sharan Murugan

Nov 7, 2021
1 min

Data Standards for Drug & Biological Product Submissions Containing Real-World Data - USFDA

This guidance provides recommendations to sponsors for complying with section 745A(a) of the 30 FD&C Act (21 U.S.C. 379k-1(a)) when...

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USFDA’s Real-World Data: Assessing e-Health Records & Med Claims Data To Support Regulatory Decision

Sharan Murugan

Sep 29, 2021
2 min

USFDA’s Real-World Data: Assessing e-Health Records & Med Claims Data To Support Regulatory Decision

On 28-September, 2021 USFDA released the guidance “Real-World Data: Assessing Electronic Health Records and Medical Claims Data To...

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