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Sharan Murugan
- Aug 19, 2021
- 1 min
Guidance on Issuing of an Authorization for Med Device based on ASEAN Requirements - PhilippinesFDA
The Philippine Food and Drug Administration (FDA) released an addendum to circular (to FDA Circular No. 2021-002) on the transition to...
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Sharan Murugan
- Aug 13, 2021
- 2 min
FY2022 User Fee Table -USFDA
The User Fee programs help the Food and Drug Administration (FDA) to fulfill its mission of protecting public health and accelerating...
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Sharan Murugan
- Aug 6, 2021
- 1 min
MDCG Guidance on UDI Integration -European Comission
Medical Device Coordination Group Document (MDCG) published a guidance (MDCG 2021-19) note integration providing recommendations on how...
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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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