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Sharan Murugan
- Jan 13
- 1 min
EMA: Guidance on Paediatric Submissions & Scientific Guidelines with SmPC Recommendations
Developing drugs specifically for paediatric use comes with its own set of challenges, including ethical considerations, appropriate...
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Sharan Murugan
- Jan 5
- 2 min
UK MHRA: Guidance on 150-Day Assessment for National Applications for Medicines
Earlier today (05 January 2024) UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidance on "150-day...
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Sharan Murugan
- Jan 2
- 1 min
UK MHRA: Guidance on Operational Information Sharing
Earlier today (02 January 2024) UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidance on "Operational...
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Sharan Murugan
- Dec 30, 2023
- 2 min
USFDA : CMC Guidance Reformulating Drug Products That Contain Carbomers & Potency Assurance for Cellular & Gene Therapy Products
The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research...
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Sharan Murugan
- Dec 27, 2023
- 2 min
USFDA Guidance: Considerations, Master Protocols for the Development of Drugs and Biological Products
The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research...
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