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Sharan Murugan
23 hours ago2 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...
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Sharan Murugan
23 hours ago2 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...
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Sharan Murugan
6 days ago2 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...
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Sharan Murugan
6 days ago2 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On 07 January 2025, the U.S. Food and Drug Administration (FDA) released the draft guidance titled " Developing Drugs for Optical Imaging...
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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...
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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The U.S. Food and Drug Administration (FDA) has issued a draft guidance document titled “ Artificial Intelligence-Enabled Device Software...
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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USFDA Draft Guidance: Considerations for the Use of Artificial Intelligence to Support Regulatory Decision
The U.S. Food and Drug Administration (FDA) released a draft guidance earlier today (07 January, 2025) outlining " Considerations for...
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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 "...
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Sharan Murugan
Jan 62 min read
USFDA Guidance: Considerations for Complying with 21 CFR 211.110
The US Food and Drug Administration (FDA) has released the Draft Guidance document titled " Considerations for Complying with 21 CFR...
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Sharan Murugan
Jan 22 min read
UK MHRA Guidance: 150-Day Assessment for National Applications for Medicines & Procedures for UK Paediatric Investigation Plans (PIPs)
The UK Medicines and Healthcare Products Regulatory Agency (MHRA) continues to innovate in the regulatory space with updated processes...
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Sharan Murugan
Dec 28, 20242 min read
Latest ICH Guidance updates: M15-Model-Informed Drug Development, E6(R3)-Good Clinical Practice: Annex 2, & E11A -Pediatric Extrapolation
The International Council for Harmonisation (ICH) continues to advance global standards in drug development and clinical practices with...
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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...
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Sharan Murugan
Dec 21, 20242 min read
USFDA Guidance: Global Unique Device Identification Database (GUDID): Enhancing Medical Device Transparency
The U.S. Food and Drug Administration (FDA) has updated and released its " Global Unique Device Identification Database (GUDID) " Â final...
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Sharan Murugan
Dec 21, 20243 min read
EMA Guidance: Pre-Authorisation Procedural Advice for Users of the Centralised Procedure
The European Medicines Agency (EMA)Â has issued comprehensive guidance " European Medicines Agency Pre-Authorisation Procedural Advice for...
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Sharan Murugan
Dec 21, 20242 min read
UK MHRA: Guidance on the Licensing of Biosimilar Products
The Medicines and Healthcare products Regulatory Agency (MHRA)Â has updated its guidance on the " Licensing of Biosimilar Products "Â in...
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Sharan Murugan
Dec 21, 20242 min read
UK MHRA Guidance: Variations to Marketing Authorisations (MAs)
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published (20 December 2024) updated guidance " Variations to...
28 views0 comments
Sharan Murugan
Dec 15, 20242 min read
SAHPRA's: Guidelines for Medical Device Adverse Event Reporting
The South African Health Products Regulatory Authority (SAHPRA) has released two crucial guidelines to streamline adverse event reporting...
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Sharan Murugan
Dec 15, 20242 min read
TGA: Australian Regulatory Guidelines for Medical Devices (ARGMD)
The Australian Regulatory Guidelines for Medical Devices (ARGMD) , issued by the Therapeutic Goods Administration (TGA), provide a...
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Sharan Murugan
Dec 15, 20242 min read
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...
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Sharan Murugan
Dec 15, 20242 min read
UK MHRA Guidance: Applying for a Licence to Market a Medicine in the UK
The Medicines and Healthcare Products Regulatory Agency (MHRA) Â has published updated guidance " Applying for a Licence to Market a...
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