Search
MHRA Guidance: Good Clinical Practice (GCP) for Clinical Trials
The Medicines and Healthcare Products Regulatory Agency (MHRA)Â has released updated guidance on " Good Clinical Practice (GCP)Â for...
Sharan Murugan
Mar 153 min read
11 views
0 comments
India CDSCO: Adding Trial Sites and Changing Principal Investigators
Clinical trials are a cornerstone of medical advancement, requiring meticulous planning and adherence to regulatory guidelines. In India,...
Sharan Murugan
Mar 33 min read
9 views
0 comments
UK MHRA Guidance: Managing Clinical Trial Authorisations & Safety Reporting (Updated 2025)
The UK Medicines and Healthcare products Regulatory Agency (MHRA)Â has updated its guidance on " Clinical trials for medicines: manage...
Sharan Murugan
Feb 92 min read
39 views
0 comments
USFDA Guidance: Developing Drugs for Optical Imaging – A Comprehensive Insight
On 07 January 2025, the U.S. Food and Drug Administration (FDA) released the draft guidance titled " Developing Drugs for Optical Imaging...
Sharan Murugan
Jan 112 min read
16 views
0 comments
USFDA Guidance: Technical Specifications for Submitting Clinical Trial Data Sets for Treatment of Noncirrhotic Nonalcoholic Steatohepatitis (NASH)
The U.S. Food and Drug Administration (FDA)Â has released a guidance " Technical Specifications for Submitting Clinical Trial Data Sets...
Sharan Murugan
Dec 15, 20242 min read
14 views
0 comments
USFDA Guidance: Core Patient-Reported Outcomes in Cancer Clinical Trials & Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development
The U.S. Food and Drug Administration (USFDA) yesterday (17 October, 2024)Â has issued two comprehensive Q&A guidance titled " Core...
Sharan Murugan
Oct 17, 20242 min read
8 views
0 comments
SFDA Guidance: Conducting Clinical Trials with Decentralized Elements & Integrating Randomized Controlled Trials
Guidance: Conducting Clinical Trials With Decentralized Elements The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation...
Sharan Murugan
Sep 22, 20242 min read
11 views
0 comments
UK MHRA Guidance: Clinical Trials for Medicines – Applying for Authorisation in the UK
The UK Medicines and Healthcare products Regulatory Agency (MHRA) updated their comprehensive guidance " Clinical Trials for Medicines –...
Sharan Murugan
Aug 27, 20242 min read
190 views
0 comments
UK MHRA: Guidance on Good Clinical Practice for Clinical Trials
On 22nd July 2024 the UK Medicines and Healthcare Products Regulatory Agency (MHRA) issued comprehensive guidance on " Good Clinical...
Sharan Murugan
Jul 23, 20242 min read
12 views
0 comments
USFDA Guidance: Cancer Clinical Trial Eligibility Criterias
The U.S. Food and Drug Administration (FDA) Oncology Center of Excellence, Center for Drug Evaluation and Research, and Center for...
Sharan Murugan
Apr 27, 20242 min read
8 views
0 comments
Malaysian Guideline for Application of Clinical Trial Import Licence (CTIL) & Clinical Trial Exemption (CTX)
Malaysia's National Pharmaceutical Regulatory Agency (NPRA) released an updated guideline on "Guideline for Application of Clinical Trial...
Sharan Murugan
Mar 29, 20242 min read
60 views
0 comments
USFDA Guidance: Use of Data Monitoring Committees in Clinical Trials
Today (13 February 2024) the U.S. Food and Drug Administration (FDA) Center for Biologics Evaluation and Research, Center for Devices...
Sharan Murugan
Feb 13, 20242 min read
25 views
0 comments
USFDA Guidance: Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Products
FDA announced on Monday (29-January-2024) that a draft guidance for the industry is available titled, "Collection of Race and Ethnicity...
Sharan Murugan
Jan 31, 20241 min read
26 views
0 comments
Saudi Arabia’s (SFDA): Requirements for Clinical Trials of Medical Devices
The Saudi Food and Drug Authority (SFDA) issued a comprehensive updated guidance titled "Requirements for Clinical Trials of Medical...
Sharan Murugan
Dec 30, 20231 min read
31 views
0 comments
MHRA Guidance: Common Issues Identified during Clinical Trial Applications
Yesterday (06 November 2023) the UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidance on "Common...
Sharan Murugan
Nov 7, 20231 min read
43 views
0 comments
USFDA Guidance: Submitting Patient-Reported Outcome Data, Clinical Trial Datasets & Documentation
Today (06 November, 2023) the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) released two final...
Sharan Murugan
Nov 6, 20232 min read
16 views
0 comments
UK MHRA: Clinical Trials for Medicines: Apply for Authorisation in the UK
Recently (12 October 2023) UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidance on "Clinical Trials...
Sharan Murugan
Oct 14, 20232 min read
20 views
0 comments
USFDA Guidance: Conduct of Clinical Trials of Medical Products During Major Disruptions
Today (21 September 2023) CDER, along with the FDA Center for Biologics Evaluation and Research, Center for Devices and Radiological...
Sharan Murugan
Sep 21, 20231 min read
27 views
0 comments
USFDA Guidance: Considerations for Optimizing & Standardizing Diet in Clinical Trials (IEM)
Yesterday (11 July, 2023) the USFDA's Center for Drug Evaluation and Research (CDER) released updated guidance on "Inborn Errors of...
Sharan Murugan
Jul 12, 20231 min read
36 views
0 comments
UK MHRA Guidance: Clinical Trials for Medicines: Apply for Authorisation in the UK
Yesterday (27 June 2023) UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidance on "Clinical Trials...
Sharan Murugan
Jun 27, 20231 min read
47 views
0 comments