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Sharan Murugan
- 3 days ago
- 2 min
USFDA: Guidance on Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological Products
The U.S. Food and Drug Administration, yesterday announced the release of a draft guidance, Essential Drug Delivery Outputs for Devices...
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Sharan Murugan
- 3 days ago
- 2 min
Saudi's SFDA: Guidance on Regulatory Framework for Drugs Approval
The Saudi Food & Drug Authority (SFDA) has released updated guidance on "Regulatory Framework for Drugs Approval". This comprehensive...
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Sharan Murugan
- 3 days ago
- 2 min
EC MDCG: Guidance on Clinical Evaluation of Orphan Medical Devices
The European Commission Medical Device Coordination Group (MDCG) has issued a new guidance "Clinical Evaluation of Orphan Medical...
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Sharan Murugan
- Jun 23
- 2 min
TGA Guidance: Regulatory Obligations for Exempt Medical Devices
The Therapeutic Goods Administration (TGA) in Australia has issued guidance (21 June, 2024) on the "Regulatory Obligations for Exempt...
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Sharan Murugan
- Jun 23
- 2 min
Swissmedic Guidance: Requesting Product Certificates (CPP)
Swissmedic, the Swiss Agency for Therapeutic Products, has issued a detailed guidance document "Requesting Certificates of Pharmaceutical...
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