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Sharan Murugan
May 312 min read
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Recently the International Council for Harmonisation (ICH) announced on 24 May, 2024 the availability of draft guidance for the industry...
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Sharan Murugan
Apr 162 min read
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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Sharan Murugan
Dec 19, 20232 min read
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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Sharan Murugan
Sep 8, 20221 min read
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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Sharan Murugan
Dec 11, 20212 min read
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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Sharan Murugan
Nov 7, 20211 min read
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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Sharan Murugan
Sep 29, 20212 min read
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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