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USFDA Public Consultation: HL7 FHIR for Study Data from Real-World Data
The U.S. Food and Drug Administration (FDA)Â has announced a major initiative by opening a public docket seeking comments on the "...

Sharan Murugan
Apr 273 min read
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ICH Seeks Market Consultation for Global Post-Approval CMC Assessment Cloud Solution
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)Â has issued a Request for...

Sharan Murugan
Nov 30, 20242 min read
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Singapore's HSA: Consultation on eCTD Implementation & Risk Classification on IVD
On 2nd May, 2023 Singapore's Health Sciences Authority (HSA) invited the industry to participate in the consultation on eCTD submissions...

Sharan Murugan
May 4, 20231 min read
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