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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The U.S. Food and Drug Administration (FDA) recently released (26 December 2024) draft guidance titled “ Protocol Deviations for Clinical...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...
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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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Sharan Murugan
Dec 15, 20242 min read
USFDA: CDER Establishes New Center for Real-World Evidence Innovation (CCRI)
The U.S. Food and Drug Administration’s Center for Drug Evaluation and Research (CDER)  has unveiled an innovative initiative—the CDER...
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Sharan Murugan
Dec 9, 20242 min read
USFDA Guidance: Standardized Format for Electronic Submission of NDA and BLA Content for Bioresearch Monitoring (BIMO) Inspections
The United States Food and Drug Administration (USFDA)Â has released detailed guidance" Standardized Format for Electronic Submission of...
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Sharan Murugan
Dec 9, 20242 min read
USFDA Draft Guidance: Accelerated Approval – Expedited Program for Serious Conditions
The United States Food and Drug Administration (USFDA) has released (05 December, 2024) the draft guidance " Expedited Program for...
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Sharan Murugan
Dec 9, 20242 min read
USFDA Final Guidance: Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions
The US Food and Drug Administration (USFDA) Â has issued its final guidance on " Marketing Submission Recommendations for a Predetermined...
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Sharan Murugan
Dec 4, 20242 min read
USFDA Guidance: Enhancing Communication and Guidance Development Practices
The US Food and Drug Administration (USFDA) Â has released two insightful reports aimed at improving its internal practices and...
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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...
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Sharan Murugan
Dec 4, 20242 min read
UK MHRA Press Release Trials Innovative AI Technologies in Regulatory Pilot Scheme
The UK Medicines and Healthcare Products Regulatory Agency (MHRA)Â has launched (4th December 2024) a groundbreaking pilot scheme "...
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