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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...
Sharan Murugan
Dec 28, 20242 min read
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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...
Sharan Murugan
Dec 21, 20242 min read
30 views
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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...
Sharan Murugan
Dec 21, 20243 min read
110 views
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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...
Sharan Murugan
Dec 21, 20242 min read
71 views
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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...
Sharan Murugan
Dec 21, 20242 min read
235 views
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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...
Sharan Murugan
Dec 15, 20242 min read
26 views
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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...
Sharan Murugan
Dec 15, 20242 min read
82 views
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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
15 views
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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...
Sharan Murugan
Dec 15, 20242 min read
101 views
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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...
Sharan Murugan
Dec 9, 20242 min read
33 views
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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...
Sharan Murugan
Dec 9, 20242 min read
21 views
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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...
Sharan Murugan
Dec 9, 20242 min read
16 views
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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...
Sharan Murugan
Dec 4, 20242 min read
23 views
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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...
Sharan Murugan
Dec 4, 20242 min read
69 views
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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 "...
Sharan Murugan
Dec 4, 20242 min read
29 views
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MDCG Guidance: Implementation of the Master UDI-DI Solution for Contact Lenses
In November 2024, the Medical Device Coordination Group (MDCG) Â released " MDCG 2024-14 - Guidance on the implementation of the Master...
Sharan Murugan
Nov 30, 20242 min read
12 views
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EMA Guidance: Scientific Guidelines with Summary of Product Characteristics (SmPC) Recommendations
The European Medicines Agency (EMA) Â has released a comprehensive document " Scientific guidelines with summary-of-product-characteristi...
Sharan Murugan
Nov 30, 20242 min read
186 views
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UK MHRA Issues Final Call to Comply with Windsor Framework for Medicines by January 2025
The UK Medicines and Healthcare Products Regulatory Agency (MHRA)Â has issued " Call to comply with Windsor Framework arrangements for...
Sharan Murugan
Nov 30, 20242 min read
25 views
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USFDA: Guidances to Advance Drug Development and Safety Assessments Advance Drug Development and Safety Assessments
The USFDA Â continues to innovate its regulatory landscape with the release of three important guidance earlier today (27 November, 2024)...
Sharan Murugan
Nov 27, 20242 min read
27 views
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USFDA MD Guidance: Enhancing Safety and Efficiency in Orthopedic Devices and Sterilization Processes
The USFDA Center for Devices and Radiological Health  has recently issued three key final guidance documents focusing on orthopedic...
Sharan Murugan
Nov 27, 20242 min read
11 views
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