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Swissmedic Guidnce: A Closer Look at Marketing Authorisation Transfers, DHPC, and RMP Submissions
As the Swiss life sciences sector grows increasingly global and collaborative, Switzerland’s regulatory authority, Swissmedic , continues...

Sharan Murugan
21 hours ago2 min read
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EMA’s CTIS Framework: Decoding the EMA Clinical Trial Information System-A Practical Guide for Sponsors
In an era of data-driven drug development, the European Medicines Agency (EMA) has launched a transformative regulatory framework : the...

Sharan Murugan
22 hours ago2 min read
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USFDA Guidance: Drug Development for Myelodysplastic Syndromes (MDS)
Myelodysplastic syndromes (MDS) are a group of complex, clonal blood disorders that predominantly affect older adults and may progress to...

Sharan Murugan
4 days ago2 min read
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USFDA’s Draft Guidance: Aluminum Content and Labeling for Small Volume Parenteral Drug Products in Parenteral Nutrition
Aluminum contamination in parenteral nutrition (PN) has long posed a silent but serious risk—especially to vulnerable populations like...

Sharan Murugan
Jul 23 min read
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EMA NDSG Work Plan: Inside the Network Data Steering Group Workplan 2025–2028
In an era where data drives decisions and innovation defines progress, the European Medicines Agency (EMA) and Heads of Medicines...

Sharan Murugan
Jul 23 min read
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USFDA Q&A Guidance: Remote Regulatory Assessments (RRA) and Guidance on Antibacterial Therapies (Q&A) and Early Lyme Disease
The U.S. Food and Drug Administration (FDA) has finalized its guidance document on " Conducting Remote Regulatory Assessments (RRAs) ,"...

Sharan Murugan
Jun 292 min read
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USFDA Guidance: UDI Requirements for Combination Products and Cybersecurity for Medical Devices
In June 2025, the FDA released two impactful draft guidances that significantly affect medical device and combination product...

Sharan Murugan
Jun 293 min read
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ICH E20 Draft Guideline: Understanding Adaptive Clinical Trials in Focus (2025)
The International Council for Harmonisation (ICH) has taken a major step toward modernizing clinical trial designs with the release of the...

Sharan Murugan
Jun 293 min read
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UK MHRA Guidances: 9 important Guidances on Clinical Trials Safety, Approvals, Labelling, and More
Clinical trials are the cornerstone of modern medicine, ensuring that new treatments are safe, effective, and suitable for public use....

Sharan Murugan
Jun 283 min read
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ICH & USFDA Draft Guidance: Q1 Stability Testing: The Gold Standard for Drug Shelf Life and Quality
The stability of drug substances and drug products is a cornerstone of pharmaceutical quality, ensuring that medicines remain safe,...

Sharan Murugan
Jun 233 min read
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EMA Guidance: EMA’s Implementation of ISO IDMP Standards Through Products Management Services (PMS)
To modernize and harmonize the management of medicinal product information, the European Medicines Agency (EMA)Â is actively implementing...

Sharan Murugan
Jun 232 min read
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USFDA Guidance: Post-Warning Letter Meetings Under GDUFA III: A Regulatory Pathway Toward Compliance
In the evolving regulatory landscape of generic drug manufacturing, compliance and transparency  are more crucial than ever. The FDA’s...

Sharan Murugan
Jun 182 min read
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EMA Guidance: A Guide to the HMA-EMA Real-World Evidence Catalogues
As the role of real-world data (RWD) Â and real-world evidence (RWE) Â grows in drug development, regulatory decision-making, and...

Sharan Murugan
Jun 183 min read
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UK MHRA Guidance: Get Scientific Advice from MHRA- Comprehensive Guide
Navigating the regulatory landscape for medicines in the UK can be complex, especially as requirements evolve and innovation accelerates....

Sharan Murugan
Jun 183 min read
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UK MHRA Guidance: Electronic Common Technical Document (eCTD) Submissions Update
The Medicines and Healthcare products Regulatory Agency (MHRA) published a key update on 17 June 2025 , outlining revised requirements...

Sharan Murugan
Jun 182 min read
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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)Â has released an updated guidance " ANDAs: Pre-Submission Facility Correspondence Related to...

Sharan Murugan
Jun 132 min read
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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 132 min read
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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 132 min read
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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 133 min read
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SAHPRA’s Biological Medicines Amendment Guideline - A Critical Update for Biologic Product Sponsors
The South African Health Products Regulatory Authority (SAHPRA) has released the sixth version of its Biological Medicines Amendment...

Sharan Murugan
Jun 72 min read
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