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Draft Guideline on Computerised Systems & Electronic Data in Clinical Trials -EMA
Computerised systems are being increasingly used in clinical research. The complexity of such systems has evolved rapidly during the last...

Sharan Murugan
Jun 26, 20211 min read
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Core Patient-Reported Outcomes in Cancer Clinical Trials - USFDA
This is a DRAFT GUIDANCE distributed for comment purposes only. This guidance provides recommendations to sponsors for the collection of...

Sharan Murugan
Jun 19, 20211 min read
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FDA’s New Draft Guidances on Device Postmarket Surveillance – For Comments
The US Food and Drug Administration (FDA) has issued draft guidance to help Medical Device Manufacturers comply with postmarket...

Sharan Murugan
Jun 11, 20211 min read
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