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USFDA Guidance: Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices
The U.S. Food and Drug Administration (FDA) recently released (26 December 2024) draft guidance titled “ Protocol Deviations for Clinical...
Sharan Murugan
Dec 28, 20242 min read
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UK Med Dev Guidance: Clinical Investigations for Medical Devices
The Medicines and Healthcare products Regulatory Agency (MHRA)Â has published detailed guidance " Clinical Investigation s " on...
Sharan Murugan
Dec 4, 20242 min read
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UK MHRA: Notify MHRA About a Clinical Investigation for a Medical Device
Yesterday (26 April 2024) the UK Medicines and Healthcare Products Regulatory Agency (MHRA) updated its guidance "Notify MHRA About a...
Sharan Murugan
Apr 27, 20242 min read
7 views
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UK MHRA: Guidance on Licence to Market, Export Drugs, Reclassifing Medicine s & Notifying about a Clinical Investigation for a Medical Device
This week the Medicines and Healthcare Products Regulatory Agency (MHRA) updated multiple guidelines related to medicine and medical...
Sharan Murugan
Mar 20, 20242 min read
25 views
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MHRA Guidance: Notify the MHRA about a Clinical Investigation for a Medical Device
Earlier today (17 July, 2024) UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidance on "Notify the...
Sharan Murugan
Jan 16, 20242 min read
50 views
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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)Â released multiple guidances that is related to Digital Technologies and...
Sharan Murugan
Dec 27, 20232 min read
8 views
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USFDA Guidance: Regulatory Considerations for Prescription Drug Use-Related Software
Yesterday (19 September 2023) the U.S. Food and Drug Administration (FDA) released two draft guidance "Regulatory Considerations for...
Sharan Murugan
Sep 20, 20232 min read
26 views
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USFDA Guidance: Psychedelic Drugs-Considerations for Clinical Investigations
Recently last week Friday (23 June 2023) the United States Food & Drug Administration's Center for Drug Evaluation and Research released...
Sharan Murugan
Jun 25, 20231 min read
18 views
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UK MHRA Guidance: Notifying MHRA on a Clinical Investigation for a Medical Device
Last Thursday (11 May 2023) UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated Guidance on "Notify the MHRA...
Sharan Murugan
May 13, 20232 min read
41 views
0 comments
Swiss Medic: Information sheet on Clinical Investigations with Medical Devices
Recently (13-April-2023) Switzerland's Swissmedic released an updated Information sheet document for "Information sheet on Clinical...
Sharan Murugan
Apr 17, 20231 min read
14 views
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USFDA Q&A: A Risk-Based Approach to Monitoring of Clinical Investigations
Earlier today (11th April 2023) USFDA released final guidance on"A Risk-Based Approach to Monitoring of Clinical Investigations Questions...
Sharan Murugan
Apr 11, 20231 min read
32 views
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Irelands HPRA's: Medical Device Guide to Clinical Investigations Carried Out in Ireland
On 18th November, 2022 Irelands Health Products Regulatory Authority (HPRA) released an updated Guide related to "Clinical Investigations...
Sharan Murugan
Nov 27, 20221 min read
21 views
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USFDA Guidance: Clinical Investigations of Medical Products Involving Children
A draft guidance was released on 23 September 2022 by the US Food and Drug Administration on the ethical considerations for including and...
Sharan Murugan
Sep 25, 20221 min read
22 views
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USFDA Guidance: Methods to Identify What Is Important to Patients
On 28-February-2022, the US Food and Drug Administration (FDA) finalized guidance to assist sponsors in collecting and submitting...
Sharan Murugan
Mar 3, 20221 min read
14 views
0 comments
MDCG offers Guidance on Clinical Investigations – Europe
The European Commission’s Medical Device Coordination Group (MDCG) last week issued guidance providing a set of templates that will be...
Sharan Murugan
May 28, 20211 min read
5 views
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