Search Results for Informatics

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Woodcock: CDER Informatics System is Top Priority for 2018 By Michael Mezher - Published 05 December 2017

Going into 2018, Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER) at the US Food and Drug Administration (FDA), said that her top priority will be to implement a center-wide informatics system.

Categories: News, US, CDER, Biologics and biotechnology, Compliance, Generic drugs, Over the counter drugs, Prescription drugs, Submission and registration

Tags: 21st Century Cures, Informatics, CDER

precisionFDA: A Crowd-Sourced, Cloud-Based Platform for Precision Medicine By Michael Mezher - Published 06 August 2015

The US Food and Drug Administration (FDA) has announced the launch of a new crowd-sourced, cloud-based platform, precisionFDA, to enable developers of genomic sequencing diagnostics to share data and methodologies.

Categories: News, US, FDA, Biologics and biotechnology, In vitro diagnostics, Regulatory strategy

Tags: Precision medicine, openFDA, precisionFDA, Office of Health Informatics, NGS, Next generation sequencing