PMRs: Researchers suggest changes to shorten postmarketing requirement timelines

(Source: RAPS 2018-12-14)

A new study from researchers at Yale and Dartmouth published in the Journal of General Internal Medicine finds that drugmakers often take much longer to complete US Food and Drug Administration (FDA) mandated postmarketing requirements (PMRs) than expected based on completion timelines listed on ClinicalTrials.gov.


US: FDA drafts guidance on biomarker qualification

(Source: RAPS 2018-12-13)

The US Food and Drug Administration (FDA) on Tuesday released draft guidance for industry discussing the recommended components of a biomarker development program, including how to determine the type and level of evidence sufficient to support qualification, and how these components interrelate to inform an evidentiary framework.


R&D: Scientists develop revolutionary tech to improve prostate cancer detectiony

(Source: PharmaTimes 2018-12-12)

A ‘revolutionary’ new medical software able to pinpoint the area from which surgeons should take a biopsy to detect prostate cancer has been developed by NIHR supported researchers.

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