Drugs

Consultants See Industry Gains in FDA Quality Plan

Paragon Consulting says that FDA is delaying implementation of its 2013 Quality Metrics Initiative that will ultimately drive significant change in the way life sciences companies monitor and evaluate operational and quality performance. In an online report, Paragon says that as a result of refinements to two draft guidances and active public comments on the initiative, the agency first delayed implementation of the program and instead planned to open a voluntary submission program in 2018. However, even that voluntary program has been postponed due to additional challenges revealed in a review of the agency’s technical conformance guide that accompanied the latest guidance in 2016, it says.

“The delay will allow both the agency and industry to better prepare for the submission of meaningful quality data elements,” Paragon says, “and it will provide the opportunity to continue to refine the metrics currently under consideration.”

The report says that progress achieved on the initiative since 2013 had made it clear that FDA and industry “are aligned on fostering a data-driven quality culture across the industry. Both groups support a risk-based approach to inspection management and quality monitoring. However, it is clear that the insights necessary to support this model can only come by taking advantage of digital age technological advances that support process harmonization, and revolutionary data visibility/information management practices. The Quality Metrics Initiative is, in effect, driving the industry towards a common master data management approach (starting with the 14 master data elements currently requested) and a harmonized view of key quality, operations, and distribution transactions.”

The consultants suggest that firms that prioritize creating a foundational connected quality approach that integrates quality and operations data across their business systems in a validated integration layer, and who invest in a scalable business intelligence capability on top of that layer, will be best positioned to contribute to the continued refinement of the Quality Metrics Initiative. It lists business benefits that can accrue to companies taking such an approach.

“In the end,” the report concludes, “firms will have to invest to comply with the FDA Quality Metrics Initiative, but they can use that instrument as a foundation to build a competitive advantage beyond compliance that will serve their business for years to come.”

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome