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FDA Revives Its Proposed Quality Metrics for Pharma and Clarifies Device Cybersecurity Recommendations + Warning Letter Breakdown

We look inside the latest iteration of FDA's proposed Quality Metrics program, explore new expectations for device cybersecurity, and break down a warning letter citing faulty study data.

Welcome to Insider issue #5.

And welcome to the 133 new life science professionals who joined last month.

Today, we’re covering FDA’s recent revisions to its pared-down plan to collect quality metrics data from pharma manufacturers. Regulators are renewing their earlier (stalled) effort to collect manufacturing quality data to mitigate potential drug shortages and promote enhanced quality management across the industry.

Read the pared-down quality metrics plan here in the Federal Register.

Earlier in 2022, FDA announced that this program would be different from the original quality metrics draft guidance unveiled in 2015, as well as the revised draft guidance issued in 2016. The newly devised plan is based on the feedback FDA received through its voluntary quality metrics site visit and quality metrics feedback programs launched in 2018.

On the device side, we’re covering FDA’s new cybersecurity draft guidance, which will replace its 2014 guidance once finalized. Specifically, we look at what is actually impacted and how it might affect device companies.

Lastly, we’ll break down a warning letter to a domestic CRO citing GLP issues—specifically how both a Study Director and QA team failed to spot miscalculations in study data.

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The FDA Group