Search Results for Quality Metrics

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Industry Wants FDA to Hit the Brakes on Quality Metrics Program By Michael Mezher - Published 30 March 2017

The US Food and Drug Administration's (FDA) proposed quality metrics program is proving to be a bitter pill for the pharmaceutical industry to swallow.

Categories: News, US, FDA, Active pharmaceutical ingredients, Biologics and biotechnology, Drugs, Manufacturing, Quality

Tags: Quality Metrics

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Tags: Quality Metrics, Revised draft guidance

FDA to Revise Draft Guidance on Quality Metrics Data By Zachary Brennan - Published 12 September 2016

The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) on Monday offered a couple of revisions to its list of guidance documents for 2016. Most notably, a revision to the agency’s draft guidance on quality metrics is expected later this year.

Categories: News, US, FDA, Active pharmaceutical ingredients, Compliance, Drugs, Government affairs, Manufacturing, Quality

Tags: quality metrics, pharmaceutical quality, FDA quality metrics guidance, CDER draft guidance

Quality Metrics: FDA Outlines What Data to Submit By Zachary Brennan - Published 24 June 2016

The technical reference document released Friday from the US Food and Drug Administration (FDA) provides recommendations to pharmaceutical companies on the submission of records and other information to support FDA’s calculation of quality metrics as part of the process validation lifecycle and pharmaceutical quality system (PQS) assessment.

Categories: News, US, FDA, Active pharmaceutical ingredients, Compliance, Drugs, Due Diligence, Government affairs, Manufacturing

Tags: FDA quality metrics, OPQ, drug quality

FDA's New Office of Pharmaceutical Quality By Douglas W. Balogh, PhD, Suzanne O'Shea, JD - Published 09 February 2016

The Center for Drug Evaluation and Research Office of Pharmaceutical Quality (OPQ) was launched in 2015. This article examines FDA's reasons for implementing a major change to oversight of manufacturing quality and the implications for consumers, sponsors and regulatory professionals.

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

Tags: Office of Pharmaceutical Quality, OPQ, Quality Metrics,

Califf Vows Not to Lower or Remove FDA Regulations By Zachary Brennan - Published 11 January 2016

President Barack Obama’s US Food and Drug Administration (FDA) commissioner nominee Robert Califf, who faces a Senate committee vote Tuesday, told legislators in written comments that he does not support the lowering or removal of regulations at FDA, though he previously said they were a barrier to innovation.

Categories: Biologics and biotechnology, Compliance, Drugs, Ethics, Government affairs, Manufacturing, Medical Devices

Tags: Califf, FDA, quality metrics, foreign drug inspections, Lamar Alexander

Industry Calls for Clarity, Phased Approach for Quality Metrics By Michael Mezher - Published 04 December 2015

Pharmaceutical industry groups say they support the US Food and Drug Administration's (FDA) plan to request quality metrics from drugmakers, but they also call on the agency to clarify what it wants and implement a phased-in approach.

Categories: News, US, FDA, Biologics and biotechnology, Drugs, Manufacturing, Postmarket surveillance, Quality, Regulatory strategy

Tags: Quality Metrics, PhRMA, GPhA, BIO

Quality Characteristics From a Regulatory Perspective By Max Sherman - Published 23 September 2015

This article presents information, terminology and references addressing violations from inspections conducted by FDA investigators or Notified Bodies.

Tags: quality characteristics, FDA, quality metrics, FDA guidance

Quality Metrics: Industry Reaction to FDA's Draft Guidance By Michael Mezher - Published 25 August 2015

On Monday, the US Food and Drug Administration (FDA) held a public meeting to discuss its plan to request quality metrics from drug manufacturers. The meeting was the first opportunity for the agency and industry to publicly discuss the plan since FDA released its draft guidance in July.

Categories: News, US, FDA, Biologics and biotechnology, Drugs, Manufacturing, Postmarket surveillance, Quality, Regulatory strategy

Tags: Quality metrics, Inspections, Office of Pharmaceutical Quality, PhRMA, GPhA