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Sharan Murugan
- Jul 29, 2021
- 1 min
Guideline on Quality Documentation for Drug-Device Combination Products - EMA
The European Medicines Agency (EMA) on 22-July-2021 has adopted a guideline on the quality information that manufacturers of combination...
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Sharan Murugan
- Jul 28, 2021
- 1 min
ICH Q13 Draft Guideline reaches Step 2 of the ICH process
ICH on 27 July 2021, confirmed that the ICH Q13 Guideline on Continuous Manufacturing of Drug Substances and Drug Products reached Step 2...
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Sharan Murugan
- Jul 28, 2021
- 1 min
FDA’s revised MAPP Procedures for Generic Drug Labeling Change
FDA on July 26, 2021, published a revision to the Manual of Policies and Procedures (MAPP 5230.3), “Generic Drug Labeling Revisions” The...
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Sharan Murugan
- Jul 19, 2021
- 1 min
Guidance on Packaging for Human Medicinal Products, Med.Prod Names & eSubmissions platform - Swiss
Guidance document Packaging for Human Medicinal Products HMV4 This guidance document explains how primary and secondary packaging...
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Sharan Murugan
- Jul 13, 2021
- 1 min
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) – EMA
European Medicines Agency (EMA) has assessed several rare adverse events for COVID-19 vaccines and one gene therapy for treating...
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