Due to the limitations inflicted by the pandemic, Remote Interactive Evaluations (RIEs) are becoming an important part of regulatory decision-making. Specifically, the FDA is using RIEs to limit unnecessary contact.
In part one of this two-part series, we defined remote interactive evaluations and discussed their nature, uses, and goals. Part two will focus on what to expect from the evaluation process.
What Might Be Discussed During the Initial Virtual Meeting?
Once a facility agrees to an RIE, the FDA schedules a short virtual meeting. During this meeting, the two parties discuss the evaluation process.
Some examples of what may be included in the initial virtual meeting are:
- Discussion of goals and scope of the evaluation.
- Introduction to the FDA's RIE team and lead.
- Identification of the facility's point of contact and introduction to all other participants.
- Scheduling of virtual walkthroughs and other activities to support the evaluation.
- Resolution of possible communication issues (different time zone differences or the need for translators).
- Identification of virtual communication methods and possible technological limitations.
- Confirmation of the facility's technical capabilities to support the evaluation.
Discussion topics will differ depending on the RIE.
What Might the FDA Include as Part of the RIE?
During the remote interactive evaluation, you can expect the FDA to:
- Request and review documents, records, and other information.
- Conduct interviews and meetings with the staff.
- Examine facilities, operations, and data through live-streaming technology or pre-recorded videos.
- Evaluate the facility's corrective actions (when RIEs are conducted for follow-up and compliance inspections).
- Ask for verbal updates on observations and outstanding issues (when applicable).
It's important to be just as prepared for an RIE as you would be for a regular in-person inspection. Otherwise, you may impede the agency's ability to make timely regulatory decisions. Preparation also makes the RIE much simpler than it otherwise would be.
How Do You Fulfill Requests for Documentation?
To facilitate virtual evaluations, the FDA usually requests and reviews documents in advance. However, the agency may request additional documents and data during the evaluation. Documents requested before and during the RIE should be provided within a reasonable timeframe, just as you would for an inspection.
Documents should be available in an electronic format or through screen-sharing technology. The FDA provides secure tools for file sharing.
What Happens During the Closeout Meeting?
After the evaluation is over, the FDA will schedule a closeout meeting where the agency will provide a list of observations so both parties can discuss them in detail and come up with an appropriate response.
The list of observations isn't the agency's final action or decision. No Inspectional Observations or 483 observations will be issued.
The FDA encourages the facility to respond to the observations during the meeting or within 15 U.S. business days.
If, based on the RIE, the FDA decides that an in-person inspection is necessary, it will use the gathered information to prepare for and conduct the inspection.
Understanding Remote Interactive Evaluations
Remote interactive evaluations are designed to improve the regulatory decision-making process during the pandemic. They enable oversight of facilities that may not be accessible in person due to travel restrictions. RIEs also minimize risks associated with in-person contact.
Understanding the nature and purpose of RIEs can help organizations prepare for evaluations. This can streamline the approval process and speed up the marketing assessment of drugs and biologics.
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