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USFDA Guidance: ANDAs: Pre-Submission Facility Correspondence Related to Prioritized Generic Drug Submissions
The U.S. Food and Drug Administration (FDA) has released an updated guidance " ANDAs: Pre-Submission Facility Correspondence Related to...
Sharan Murugan
Jun 13, 20252 min read
EMA’s User Guide: HMA-EMA Catalogues of Real-World Data Sources and Studies
The integration of real-world data (RWD) into regulatory decision-making is transforming the landscape of pharmaceutical development and...
Sharan Murugan
Jun 13, 20252 min read
UK MHRA Guidance: GLP-1 Medicines for Weight Loss and Diabetes: What You Need to Know
In recent years, GLP-1 receptor agonists have gained widespread attention for their dual role in type 2 diabetes management and weight...
Sharan Murugan
Jun 13, 20252 min read
UK MHRA's Guidance: UK’s Decentralised Manufacture Framework: A Holistic Overview
In the evolving landscape of pharmaceutical manufacturing, Decentralised Manufacture has emerged as a pivotal approach, especially in...
Sharan Murugan
Jun 13, 20253 min read
Swissmedic’s Clinical Trial Guidance Suite: Everything Sponsors Need to Know
On June 2, 2025 , Swissmedic published a harmonised suite of guidance documents to standardise, streamline, and digitalise the clinical...
Sharan Murugan
Jun 7, 20252 min read
USFDA Guidance: M11 Technical Specification & Template: Clinical Electronic Structured Harmonised Protocol (CeSHarP)
In a major step toward global harmonisation of clinical trial processes, the U.S. Food and Drug Administration (FDA) and the...
Sharan Murugan
Jun 7, 20252 min read
Meet ELSA: USFDA Launches Agency-Wide AI Tool to Optimize Performance
What if the agonizing wait for drug approvals could be slashed from days to minutes? Imagine a future where breakthrough therapies reach...
Sharan Murugan
Jun 2, 20252 min read
USFDA’s Draft Guidance: Bioequivalence Biowaivers for Additional Strengths of Immediate-Release Oral Drugs
Developing drug products across multiple strengths is a common strategy in pharmaceutical formulation, allowing dose flexibility and...
Sharan Murugan
May 30, 20252 min read
USFDA Draft Guidance: Replacing Color Additives in Approved or Marketed Drug Products
A color additive is any dye, pigment, or substance that imparts color to a drug. Only color additives listed in FDA regulations are...
Sharan Murugan
May 30, 20252 min read
EMA Guidance: EudraVigilance Registration Manual -Step-by-Step Guide to Compliance and Signal Management
Pharmacovigilance is critical for ensuring drug safety in the EU. EudraVigilance is the central system operated by the European Medicines...
Sharan Murugan
May 24, 20253 min read
UK MHRA's Guidance: Use of Real-World Data in Clinical Studies for Regulatory Decisions
The integration of real-world data (RWD) in clinical research is revolutionizing the pharmaceutical landscape. The Medicines and...
Sharan Murugan
May 22, 20252 min read
UK MHRA Guidance: Navigating the UK National Assessment
Understanding and navigating the UK's regulatory requirements is crucial for pharmaceutical companies aiming to obtain marketing...
Sharan Murugan
May 22, 20252 min read
Swissmedic’s Guidance: Authorisation of Co-Marketing Medicinal Products
Companies increasingly turn to co-marketing partnerships in today’s highly competitive pharmaceutical landscape to expand product reach,...
Sharan Murugan
May 21, 20252 min read
EMA Policy 0070 Guidance: Transparency in Clinical Data Publication – Version 1.5 (May 2025)
The European Medicines Agency (EMA) has long committed to this principle through Policy 0070, which governs the publication of clinical...
Sharan Murugan
May 17, 20253 min read
UK MHRA Guidance: International Recognition Procedure – Streamlining Access to Medicines in Great Britain
In a globally interconnected pharmaceutical landscape, regulatory collaboration is essential to ensure timely patient access to safe and...
Sharan Murugan
May 17, 20252 min read
USFDA Announcement: Shortening the Drug Approval Process- Integration of Generative AI by June end & Completion of First AI-Assisted Scientific Review
The U.S. Food and Drug Administration (FDA) has marked a significant milestone in its digital transformation journey by announcing the...
Sharan Murugan
May 13, 20252 min read
CIOMS Working Group Draft Report: Artificial Intelligence in Pharmacovigilance: Key Takeaways
The field of pharmacovigilance (PV) —the science of detecting, assessing, understanding, and preventing adverse effects or any other...
Sharan Murugan
May 13, 20253 min read
EMA Network Data Steering Group workplan 2025-2028: Leveraging Data and AI for Enhanced Medicine Regulation
In the evolving landscape of medicines regulation, data and artificial intelligence (AI) have become pivotal tools to enhance public and...
Sharan Murugan
May 11, 20253 min read
EMA Concept Paper: Advancements in Good Manufacturing Practice for Advanced Therapy Medicinal Products
The pharmaceutical industry continually evolves to adapt to new scientific discoveries and technological advancements. Good Manufacturing...
Sharan Murugan
May 11, 20253 min read
UK MHRA Guidance: The Northern Ireland MHRA Authorised Route (NIMAR)
The Medicines and Healthcare products Regulatory Agency (MHRA) has published updated guidance on " The Northern Ireland MHRA Authorised...
Sharan Murugan
May 11, 20252 min read