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FDA Finalizes Guidance on REMS Format and Content, Preparing for Expanded Device Inspection Authority + Warning Letter Breakdown

We explore FDA's expectations for the format and content of a REMS, how to prepare for more medical device inspection authority, and lessons to draw from recent high-profile FDA Warning Letters.

Welcome to Insider issue #12.

And welcome to the 213 new life science professionals who joined last month.

Today, we discuss the FDA's final guidance on the format and content of a REMS document, which outlines the expectations for manufacturers to implement specific safety measures beyond drug labeling requirements for medications with serious safety concerns.

We also touch on the FDA's newly-granted authority to request any document within a medical device manufacturer's Quality Management System (QMS) as part of their inspection and oversight powers — and how to prepare accordingly.

Lastly, we break down and draw lessons from recent high-profile Warning Letters sent to a major endoscope maker and its subsidiary for GMP issues and medical device reporting failures.

Before we get to the analysis, a quick announcement:

We recently launched a Functional Service Program, or FSP, to allow RA/QA teams to bundle their projects and consolidate their vendor managment with The FDA Group for deep discounts.

We know RA/QA teams often manage multiple project vendors, which is time-consuming, costly, and frustrating. Over time, spreading project work across several external vendors can become inefficient and open the door to miscommunication, budget overruns, and lack of visibility.

Traditional vendor relationships can also lack coordination and alignment, causing delays and mistakes. Our FSP model addresses these challenges by offering a single, reliable partner for your projects at discounted rates. The more you outsource to us, the higher your discount gets across all those rates.

One of the biggest reasons RA/QA teams are bundling services with us is the ability to easily move and deploy the same resources across multiple functional areas (avoiding costs and delays due to additional onboarding and training).

Head to our FSP page and scan through our overview guide to learn more. Interested in chatting about our FSP? Contact us any way you'd like. We'll schedule a brief discussion to answer your questions and explore a bundled engagement.

Read our FSP overview (.pdf)

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