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EMA Guidance: A Guide to the HMA-EMA Real-World Evidence Catalogues
As the role of real-world data (RWD) and real-world evidence (RWE) grows in drug development, regulatory decision-making, and...
Sharan Murugan
Jun 18, 20253 min read
EMA’s User Guide: HMA-EMA Catalogues of Real-World Data Sources and Studies
The integration of real-world data (RWD) into regulatory decision-making is transforming the landscape of pharmaceutical development and...
Sharan Murugan
Jun 13, 20252 min read
UK MHRA's Guidance: Use of Real-World Data in Clinical Studies for Regulatory Decisions
The integration of real-world data (RWD) in clinical research is revolutionizing the pharmaceutical landscape. The Medicines and...
Sharan Murugan
May 22, 20252 min read
USFDA Public Consultation: HL7 FHIR for Study Data from Real-World Data
The U.S. Food and Drug Administration (FDA) has announced a major initiative by opening a public docket seeking comments on the "...
Sharan Murugan
Apr 27, 20253 min read
USFDA Guidance: Utilizing Real-World Data in Regulatory Decision-Making for Drug and Biological Products
On July 25, 2024, the U.S. Food and Drug Administration (FDA), through its Center for Drug Evaluation and Research (CDER), Center for...
Sharan Murugan
Jul 27, 20242 min read
USFDA Guidance: Digital Health Technologies for Remote Data Acquisition & Data Standards for Drug and Biological Product Submissions and Real-World Data
Earlier this week the the U.S. Food and Drug Administration (FDA) released multiple guidances that is related to Digital Technologies and...
Sharan Murugan
Dec 27, 20232 min read
EMA Guidance: Good Practice Guide for the use of the Metadata Catalogue of Real-World Data Sources
Earlier today (27-September-2022) EMA released draft guidance on the "Good Practice Guide for the use of the Metadata Catalogue of...
Sharan Murugan
Sep 27, 20221 min read
Draft Guidance on Assessing Registries to Support Regulatory Decision -USFDAYesterday, the USFDA
Yesterday, the USFDA issued draft guidance for the industry titled Real-World Data: Assessing Registries to Support Regulatory...
Sharan Murugan
Nov 30, 20211 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...
Sharan Murugan
Sep 29, 20212 min read