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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](https://static.wixstatic.com/media/nsplsh_b58e90a363cf472d88b6f4f10478df62~mv2.jpg/v1/fill/w_399,h_300,fp_0.50_0.50,q_90,enc_auto/nsplsh_b58e90a363cf472d88b6f4f10478df62~mv2.jpg)
Sharan Murugan
- 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Recently the International Council for Harmonisation (ICH) announced on 24 May, 2024 the availability of draft guidance for the industry...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](https://static.wixstatic.com/media/nsplsh_3961614f53765745425477~mv2.jpg/v1/fill/w_399,h_300,fp_0.50_0.50,q_90,enc_auto/nsplsh_3961614f53765745425477~mv2.jpg)
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](https://static.wixstatic.com/media/nsplsh_6d56563073385a76456d34~mv2.jpg/v1/fill/w_399,h_300,fp_0.50_0.50,q_90,enc_auto/nsplsh_6d56563073385a76456d34~mv2.jpg)
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](https://static.wixstatic.com/media/nsplsh_aa08499da1d1400d86fc92b9a3de8f6f~mv2.jpg/v1/fill/w_399,h_300,fp_0.50_0.50,q_90,enc_auto/nsplsh_aa08499da1d1400d86fc92b9a3de8f6f~mv2.jpg)
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](https://static.wixstatic.com/media/nsplsh_6f9547b13fb24922885e1aa43b0c7410~mv2.jpg/v1/fill/w_399,h_300,fp_0.50_0.50,q_90,enc_auto/nsplsh_6f9547b13fb24922885e1aa43b0c7410~mv2.jpg)
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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