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Sharan Murugan
Oct 22 min read
USFDA Guidance : Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers
The U.S. Food and Drug Administration (USFDA) has issued comprehensive Q&A guidance titled " Electronic Systems, Electronic Records, and...
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Sharan Murugan
Oct 22 min read
UK MHRA Guidance: Pre-submission Advice & Support
UK's Medicines and Healthcare products Regulatory Agency (MHRA) updated and released ( 1 October 2024 ) guidance " Pre-Submission Advice...
200
Sharan Murugan
Sep 282 min read
USFDA Medical Device: Guidance on Dental Products (Dental Impression Materials, Dental Ceramics, Dental Cements and Air Powered Dental Handpieces and Air Motors)
USFDA's Center for Devices and Radiological Health has released four final guidances about dental products, such as Dental Impression...
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