Search
Sharan Murugan
Dec 28, 20242 min read
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The U.S. Food and Drug Administration (FDA) recently released (26 December 2024) draft guidance titled “ Protocol Deviations for Clinical...
96 views
0 comments
Sharan Murugan
Dec 4, 20242 min read
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...
38 views
0 comments
Sharan Murugan
Apr 27, 20242 min read
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...
7 views
0 comments
Sharan Murugan
Mar 20, 20242 min read
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...
24 views
0 comments
Sharan Murugan
Jan 16, 20242 min read
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...
50 views
0 comments
Sharan Murugan
Dec 27, 20232 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)Â released multiple guidances that is related to Digital Technologies and...
8 views
0 comments
Sharan Murugan
Sep 20, 20232 min read
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Yesterday (19 September 2023) the U.S. Food and Drug Administration (FDA) released two draft guidance "Regulatory Considerations for...
26 views
0 comments
Sharan Murugan
Jun 25, 20231 min read
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...
18 views
0 comments
Sharan Murugan
May 13, 20232 min read
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...
41 views
0 comments
Sharan Murugan
Apr 17, 20231 min read
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...
14 views
0 comments
Sharan Murugan
Apr 11, 20231 min read
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...
32 views
0 comments
Sharan Murugan
Nov 27, 20221 min read
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...
21 views
0 comments
Sharan Murugan
Sep 25, 20221 min read
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...
22 views
0 comments
Sharan Murugan
Mar 3, 20221 min read
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...
14 views
0 comments
Sharan Murugan
May 28, 20211 min read
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...
5 views
0 comments