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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The US Food and Drug Administration (FDA) has released the Draft Guidance document titled " Considerations for Complying with 21 CFR...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The U.S. Food and Drug Administration (FDA) recently released (26 December 2024) draft guidance titled “ Protocol Deviations for Clinical...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, 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
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 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 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 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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Sharan Murugan
Nov 30, 20242 min read
ICH Seeks Market Consultation for Global Post-Approval CMC Assessment Cloud Solution
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)Â has issued a Request for...
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Sharan Murugan
Nov 30, 20242 min read
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...
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Sharan Murugan
Nov 29, 20242 min read
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...
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Sharan Murugan
Nov 27, 20242 min read
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)...
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Sharan Murugan
Nov 20, 20242 min read
Australia's TGA: Listed Medicines Evidence Guidelines
Earlier today (20 November, 2024) the Therapeutic Goods Administration (TGA)Â released Version 4.0 of its Listed Medicines " Evidence...
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Sharan Murugan
Nov 16, 20242 min read
Swissmedic Guidance on Product Information for Human Medicinal Products
Swissmedic, the Swiss Agency for Therapeutic Products, has introduced its updated guidance  on " Product Information for Human Medicinal...
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Sharan Murugan
Nov 16, 20242 min read
USFDA Guidance: Nonclinical Safety Assessment of Oligonucleotide-Based Therapeutics
This USFDA draft guidance" Nonclinical Safety Assessment of Oligonucleotide-Based Therapeutic s" , issued on 15 November 2024, offers...
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Sharan Murugan
Nov 11, 20242 min read
South Africa's SAHPRA: Communication to Industry on Quality Variations
The SAHPRA released a " Communication to Industry on Quality Variations "Â document that addresses updates on the submission requirements...
29 views0 comments