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USFDA/ICH - E6(R3) GCP Guideline: Modernizing the Design & Conduct of Clinical Trials
The US Food and Drug Administration has announced earlier today (06 June, 2023) the availability of a draft guidance "E6(R3) Good...
Sharan Murugan
Jun 6, 20231 min read
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USFDA Guidance: Decentralized Clinical Trials for Drugs, Biological Products, and Devices
Today (02 May 2023) the United States Food & Drug Administration's Center for Drug Evaluation and Research, Center for Biologics...
Sharan Murugan
May 2, 20232 min read
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UK MHRA: Guidance on Good Clinical Practice for Clinical Trials
The Medicines and Healthcare Products Regulatory Agency (MHRA) recently (06 April 2023) released updated guidance on "Good Clinical...
Sharan Murugan
Apr 9, 20231 min read
184 views
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USFDA Guidance: Clinical Outcome Assessments Into Endpoints for Regulatory Decision
Earlier today (o5 April 2023) USFDA's Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, and Center...
Sharan Murugan
Apr 5, 20231 min read
48 views
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Japan's PMDA: Reporting ADR & Defects during Clinical Trials using e-Application Data System
Recently Japan's the Ministry of Health, Welfare and Labour (MHLW) - Pharmaceuticals and Medical Devices Agency issued guidance “System...
Sharan Murugan
Apr 2, 20231 min read
101 views
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USFDA Guidance: Clinical Trial Considerations to Support Accelerated Approval of Oncology Products
Earlier today (24 March 2023) USFDA's Oncology Center of Excellence released a draft guidance on "Clinical Trial Considerations to...
Sharan Murugan
Mar 24, 20231 min read
25 views
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Ireland's HPRA: Guide to Clinical Trial Applications
Recently in January, the Health Products Regulatory Authority (HPRA) of Ireland updated its guidance on "HPRA Guide to Clinical Trial...
Sharan Murugan
Feb 2, 20231 min read
34 views
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Swissmedic: Guideline Amendments Clinical Trials & Clinical Trial Application Dossier
Earlier today (23-November-2022) Swissmedic released two updated guidelines "Guideline Amendments Clinical Trials" and "Clinical Trial...
Sharan Murugan
Nov 23, 20221 min read
46 views
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IRIS Updated Guide: How to Create & Submit Scientific Applications & Accelerating Clin. Trials Plan
On 2-September, 2022 the European Medicines Agency released the updated IRIS guidance on "How to create and submit scientific...
Sharan Murugan
Sep 4, 20221 min read
9 views
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Guidance on Clinical Trial Applications -
The Drug Regulatory Authority of Pakistan (DRAP) published the draft of this guidance document on its website on 8th April 2022 inviting...
Sharan Murugan
May 18, 20221 min read
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Updated Version of Clinical Outcome Assessment Compendium -USFDA
The COA Compendium is part of the FDA’s efforts to foster patient-focused drug development. The COA Compendium is intended to facilitate...
Sharan Murugan
Dec 11, 20211 min read
12 views
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Regulations & Requirements for Conducting Clinical Trials – SFDA
Saudi Food & Drug Authority released updated guidance on Regulations and Requirements for Conducting Clinical Trials in regards to “Early...
Sharan Murugan
Dec 7, 20211 min read
144 views
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MHRA’s updated Guidance on URGENT SAFETY MEASURE – UK
This guidance has been developed to assist those involved in clinical trials disrupted as a result of COVID-19. It is relevant to those...
Sharan Murugan
Nov 20, 20211 min read
329 views
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Denmark- Updated Guidance on Implementation Of Decentralised Elements In Clinical Trials
Decentralized clinical trials cover a multitude of elements that reduce, or in some cases even eliminate, the need for the trial...
Sharan Murugan
Sep 17, 20211 min read
44 views
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UK’s Updated Guidance on Managing Clinical Trials due to COVID-19 & Access to eHealth Records -MHRA
Managing clinical trials during Coronavirus (COVID-19) On 8th September 2021, MHRA updated the guidance on How investigators and sponsors...
Sharan Murugan
Sep 11, 20211 min read
15 views
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