Search
Sharan Murugan
Feb 13 min read
USFDA Guidance: Recommendations to Reduce the Risk of Transmission of Disease Agents Associated with Sepsis and Reduce the Risk of Transmission of Mycobacterium tuberculosis
The U.S. Food and Drug Administration (USFDA) has released two important guidance documents addressing the risks of sepsis and...
18 views0 comments
Sharan Murugan
Feb 13 min read
UK MHRA Guidance: Regulatory Framework for Licensing, Importing, and Supplying Medicines in the UK
The UK Medicines and Healthcare Products Regulatory Agency (MHRA)Â has issued several guidance documents detailing the licensing,...
12 views0 comments
Sharan Murugan
Feb 13 min read
IMDRF Med Dev Guidance: Good Machine Learning Practice (GMLP) for Medical Device Development: IMDRF’s Guiding Principles
The International Medical Device Regulators Forum (IMDRF)Â has released its final guidance document (IMDRF/AIML WG/N88:2025)Â outlining...
6 views0 comments
Sharan Murugan
Jan 263 min read
South Africs's SAHPRA Guidance: on Medical Device Adverse Event Reporting
The South African Health Products Regulatory Authority (SAHPRA)Â has issued comprehensive guidelines to streamline the reporting of...
11 views0 comments
Sharan Murugan
Jan 262 min read
South Africs's SAHPRA Communication: Regulatory Information Management System – Application Withdrawal
The South African Health Products Regulatory Authority (SAHPRA)Â has issued a Communication to the industry on the process for the...
9 views0 comments
Sharan Murugan
Jan 262 min read
Malaysia’s NPRA: Drug Registration Guidance Document (DRGD), 3rd Edition, Ninth Revision January 2025
Malaysia’s Drug Registration Guidance Document (DRGD) is a cornerstone for pharmaceutical compliance. The " Drug Registration Guidance...
20 views0 comments
Sharan Murugan
Jan 263 min read
Health Canada: Validation Rules for Regulatory Transactions in eCTD and Non-eCTD Formats
Health Canada has released detailed guidances addressing the validation rules for regulatory transactions submitted in two formats: "...
26 views0 comments
Sharan Murugan
Jan 262 min read
EMA Guidance: Procedural Advice for Orphan Medicinal Product Designation
The European Medicines Agency (EMA) provided detailed revised guidance "Procedural Advice for Orphan Medicinal Product Designation " for...
5 views0 comments
Sharan Murugan
Jan 212 min read
UK MHRA Guidance: Strengthening Post-Market Surveillance for Medical Devices
On 15 January, the Medicines and Healthcare products Regulatory Agency (MHRA) released a suite of guidance outlining the new PMS...
15 views0 comments
Sharan Murugan
Jan 212 min read
USFDA Guidance: Bioanalytical Method Validation for Biomarkers
On 21st January 2025, the U.S. Food and Drug Administration's (FDA) Center for Drug Evaluation and Research issued final guidance "...
107 views0 comments
Sharan Murugan
Jan 192 min read
Swissmedic Guidance: Orphan Drug Designation (ODS)
Swissmedic has published an updated guidance for" Orphan Drug " aimed at streamlining the regulatory process for medicinal products...
14 views0 comments
Sharan Murugan
Jan 192 min read
WHO Draft Guidance: Continuous Manufacturing of Pharmaceutical Products- Points to Consider
The World Health Organization (WHO) has released the draft working document titled " Points to Consider in Continuous Manufacturing of...
14 views0 comments
Sharan Murugan
Jan 162 min read
UK MHRA Med Dev Guidance: Applying Human Factors to Medical Devices
The Medicines and Healthcare Products Regulatory Agency (MHRA) published its comprehensive guidance titled “ Applying Human Factors and...
7 views0 comments
Sharan Murugan
Jan 162 min read
USFDA Med Dev Guidance: Premarket Approval Application and Humanitarian Device Exemption Modular Review
The U.S. Food and Drug Administration (FDA) released final guidance " Premarket Approval Application and Humanitarian Device Exemption...
9 views0 comments
Sharan Murugan
Jan 112 min read
PIC/S Guidance: Remote Assessments for GMP Inspections
The Pharmaceutical Inspection Co-operation Scheme (PIC/S) Â has released its " Guidance on Remote Assessments " effective from January...
31 views0 comments
Sharan Murugan
Jan 112 min read
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...
16 views0 comments
Sharan Murugan
Jan 73 min read
USFDA Guidance Updates: A Comprehensive Look at Recent Policies and Draft Recommendations
The U.S. Food and Drug Administration (FDA) has recently issued several key guidance documents addressing critical areas in...
29 views0 comments
Sharan Murugan
Jan 72 min read
USFDA Guidance: Artificial Intelligence-Enabled Device Software Functions – Lifecycle Management and Marketing Submission Recommendations
The U.S. Food and Drug Administration (FDA) has issued a draft guidance document titled “ Artificial Intelligence-Enabled Device Software...
10 views0 comments
Sharan Murugan
Jan 72 min read
USFDA Draft Guidance: Considerations for the Use of Artificial Intelligence to Support Regulatory Decision
The U.S. Food and Drug Administration (FDA) released a draft guidance earlier today (07 January, 2025) outlining " Considerations for...
26 views0 comments
Sharan Murugan
Jan 62 min read
Swissmedic Guidance: Parallel Import and Document Protection for Medicinal Products
Swissmedic, the Swiss Agency for Therapeutic Products, has recently updated its guidance documents for " Parallel Import " and "...
10 views0 comments