Search Results for Revised draft guidance

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FDA Revises Quality Metrics Guidance, Says Program Will Be Voluntary Until 2018 By Michael Mezher - Published 23 November 2016

The US Food and Drug Administration (FDA) on Wednesday released a revised version of its proposal to collect quality metrics data from drugmakers in response to protests from industry.

Categories: News, US, FDA, Drugs, Manufacturing, Quality

Tags: Quality Metrics, Revised draft guidance

FDA Revises Draft Guidance on Certification Process for Medical Gases By Zachary Brennan - Published 24 November 2015

The revisions on the 2012 draft guidance on the certification process for medical gases includes new discussions on the labeling for final use containers and what documentation is necessary for marketers of a medical gas that are not the original manufacturer or marketer.

Categories: News, US, FDA, Compliance, Distribution, Drugs, Due Diligence, Government affairs, Medical Devices, Quality

Tags: medical gases, FDA guidance, revised draft guidance, oxygen, nitrogen, carbon monoxide