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# Law Blog Faults FDA on Remote ‘Evaluations’
- URL: https://www.fdaweb.com/law-blog-faults-fda-on-remote-evaluations/
- Published: 2023-11-07T12:00:00.000Z
- Updated: 2026-09-14T14:15:24.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155741

Attorney **Douglas Farquhar** and senior regulatory expert **Richard Lewis** (Hyman, Phelps & McNamara) say the fact that FDA has conducted fewer than 10 remote interactive evaluations (RIEs) at drug manufacturing sites since 4/2021 is a “missed opportunity,” given that on-site inspections dropped off dramatically three years ago due to Covid-19\. Writing in their firm’s *FDA Law Blog*, the two [say](https://www.thefdalawblog.com/2023/11/lots-of-fda-guidance-but-few-drug-manufacturing-remote-interactive-evaluations-we-would-call-them-virtual-inspections/?utm%5Fsource=rss&utm%5Fmedium=rss&utm%5Fcampaign=lots-of-fda-guidance-but-few-drug-manufacturing-remote-interactive-evaluations-we-would-call-them-virtual-inspections) the number of facility RIEs is a stark contrast with the number of RIEs, more than 100, conducted as part of the Bioresearch Monitoring Program.

The two also analyze FDA’s 10/2023 draft guidance about RIEs which they say contains very little that is new or different from the Covid-centered version that was released in 4/2021.

“Under the new guidance, many of the same conditions apply as under the one that was issued 30 months ago,” they write. Key provisions are:

- requests for documents and virtual inspections are both considered “remote regulatory assessments”;
- FDA does not intend to accept requests from applicants or facilities to perform an RIE;
- RIEs may specifically be used to conduct preapproval inspections;
- FDA will require facilities to accommodate the use of teleconference, livestream video, and screen-sharing of data and documents;
- the guidance applies to facilities manufacturing human drugs, biologics, and veterinary medications, and to clinical sites for drugs; and
- responses to written observations made as a result of an RIE will not be made on a form FDA-483, but facilities are still “encouraged” to file responses within 15 business days.

Farquhar and Lewis say these things were added in the new draft:

- facilities where FDA requests that an RIE be performed need to consent in writing, while it is not clear what would happen if the facility refused; and
- comments on the guidance are invited, unlike the 4/2021 guidance that was implemented immediately without public participation.