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Sharan Murugan
4 days ago2 min read
USFDA Med Dev Guidance: Premarket Approval Application and Humanitarian Device Exemption Modular Review
The U.S. Food and Drug Administration (FDA) released final guidance " Premarket Approval Application and Humanitarian Device Exemption...
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Sharan Murugan
Jan 112 min read
PIC/S Guidance: Remote Assessments for GMP Inspections
The Pharmaceutical Inspection Co-operation Scheme (PIC/S) Â has released its " Guidance on Remote Assessments " effective from January...
220
Sharan Murugan
Jan 112 min read
USFDA Guidance: Developing Drugs for Optical Imaging – A Comprehensive Insight
On 07 January 2025, the U.S. Food and Drug Administration (FDA) released the draft guidance titled " Developing Drugs for Optical Imaging...
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