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Sharan Murugan
- Jul 27
- 2 min
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...
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Sharan Murugan
- Dec 27, 2023
- 2 min
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...
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Sharan Murugan
- Sep 27, 2022
- 1 min
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Earlier today (27-September-2022) EMA released draft guidance on the "Good Practice Guide for the use of the Metadata Catalogue of...
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Sharan Murugan
- Nov 30, 2021
- 1 min
Draft Guidance on Assessing Registries to Support Regulatory Decision -USFDAYesterday, the USFDA
Yesterday, the USFDA issued draft guidance for the industry titled Real-World Data: Assessing Registries to Support Regulatory...
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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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