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USFDA: CDER Establishes New Center for Real-World Evidence Innovation (CCRI)
The U.S. Food and Drug Administration’s Center for Drug Evaluation and Research (CDER)  has unveiled an innovative initiative—the CDER...
Sharan Murugan
Dec 15, 20242 min read
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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
Recently the International Council for Harmonisation (ICH) announced on 24 May, 2024 the availability of draft guidance for the industry...
Sharan Murugan
May 31, 20242 min read
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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...
Sharan Murugan
Apr 16, 20242 min read
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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...
Sharan Murugan
Dec 19, 20232 min read
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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...
Sharan Murugan
Sep 8, 20221 min read
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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...
Sharan Murugan
Dec 11, 20212 min read
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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...
Sharan Murugan
Nov 7, 20211 min read
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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...
Sharan Murugan
Sep 29, 20212 min read
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