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Alerts and Updates

New FDA Guidance Embraces "Remote Interactive Evaluations" but Stops Short of Permitting Virtual 704(a) Inspections

April 19, 2021

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As the guidance makes clear, what FDA calls a “remote interactive evaluation” is “not the same as an inspection” under Section 704(a) of the Federal Food, Drug and Cosmetic Act.

On April 14, 2021, the U.S. Food and Drug Administration issued formal guidance addressing the circumstances under which it will conduct “remote interactive evaluations” of drug manufacturing and bioresearch monitoring facilities in light of the ongoing COVID-19 public health emergency, which has pushed many previously in-person activities onto virtual platforms over the past 13 months.

While the new guidance demonstrates a degree of flexibility and accommodation under the present circumstances, FDA’s recommendations fall short of addressing all of the concerns of manufacturers who have asked FDA to utilize remote or virtual formats for full-fledged “inspections.” As the guidance makes clear, what FDA calls a “remote interactive evaluation” is “not the same as an inspection” under Section 704(a) of the Federal Food, Drug and Cosmetic Act. As a result, such virtual “evaluations” will be limited in terms of impact.

Key Takeaways from the Guidance

Decision to Hold a Remote Interactive Evaluation

FDA—not the applicable facility subject to evaluation—can request to perform a remote interactive evaluation whenever, in the program office’s judgment, a virtual evaluation is appropriate given mission needs and relevant travel limitations. Importantly, the guidance makes clear that FDA will not accept requests for remote interactive evaluation from applicants or facilities. Rather, FDA will first request the virtual evaluation, and the applicant or facility must then agree to be evaluated remotely.

Conducting the Remote Interactive Evaluation

When conducting a remote interactive evaluation, FDA will use its own IT platforms and equipment; according to the guidance, it currently uses FDA Microsoft Teams, FDA Zoom for Government and FDA Adobe Connect. As part of the evaluation, FDA may, among other things, request and review documents, records or other types of information; schedule interviews and meetings to address questions or concerns; and evaluate a facility’s corrective action, although a formal inspection (as opposed to an “evaluation”) may be required where necessary to verify the sufficiency of some corrective actions or if evaluating the corrective actions would unreasonably extend the duration of the virtual evaluation.

Results of Remote Interactive Evaluations

After the remote evaluation, FDA will hold a closeout meeting with the facility’s management and will usually present a written list of observations (if any); note, though, that the written list of observations will not be a final agency action and that FDA will not issue a Form FDA 483. According to the guidance, the information and documentation collected during the remote interactive evaluation may be used by FDA to, among other things, (i) support FDA’s assessment of pending applications, including whether to approve an application; (ii) support a regulatory meeting, warning letter, import alert, recall activities or enforcement action; and (iii) rank or prioritize a given facility for an inspection, particularly a surveillance CGMP inspection.

Guidance Details and Duration

The policy contained in the guidance is, according to FDA, only intended to remain in effect for the duration of the current COVID-19-related public health emergency.

More detailed information, including recommendations particularly applicable to certain types of evaluations, are included in the guidance.

About Duane Morris

Duane Morris has created a COVID-19 Strategy Team to help organizations plan, respond to and address this fast-moving situation. Contact your Duane Morris attorney for more information. Prior Alerts on the topic are available on the team’s webpage.

For More Information

If you have any questions about this Alert, please contact Frederick R. Ball, Patrick C. Gallagher, Ph.D., Justin M. L. Stern, any of the attorneys in our Life Sciences and Medical Technologies Industry Group or the attorney in the firm with whom you are regularly in contact. 

Disclaimer: This Alert has been prepared and published for informational purposes only and is not offered, nor should be construed, as legal advice. For more information, please see the firm's full disclaimer.