FDA Releases Guidance on Remote Interactive Evaluations During COVID-19

FDA’s Use of Remote Interactive Evaluations

 Per the Guidance, FDA may request to conduct a remote interactive evaluation in any of its drug inspection programs, including preapproval inspections, prelicense inspections, postapproval inspections, surveillance drug quality inspections, BIMO inspections, and follow-up and compliance inspections (e.g., inspections to investigate issues arising from defect reports or corrective actions taken in response to a warning letter or regulatory meetings). Importantly, however, FDA stated that it is unlikely to request these evaluations when there are data integrity or other issues that require an inspection.

If FDA decides to conduct a remote interactive evaluation, the agency will inform the applicant and/or the facility. The Guidance makes clear that FDA will not accept requests from applicants or facilities for a remote interactive evaluation. Notably, a facility may decline FDA’s request for a remote interactive evaluation, but it should carefully consider the implications of such a decision as that could affect the agency’s ability to make timely regulatory decisions on pending applications and, potentially, FDA’s view of the compliance status of the site.

After the facility has confirmed its willingness and ability to host an evaluation, FDA will schedule a brief virtual meeting to discuss logistics and expectations with the facility’s staff. During the remote interactive evaluation, FDA may

• request and review documents and records
• use livestream or prerecorded video to evaluate facilities, operations, and other information
• evaluate a facility’s corrective actions (e.g., in response to a previous inspection or evaluation or to the current remote interactive evaluation)
• provide verbal updates to the facility on observations and outstanding issues, whenever feasible

As with an inspection, FDA expects that documents and other information requested during the evaluation be provided within a reasonable timeframe. At the close of a remote interactive evaluation, FDA will hold a closeout meeting with the facility’s management to provide a written list of observations, if any. The list of observations will not be a final agency action or decision. FDA recommends that a facility respond to any observations during the closeout discussion or in writing within 15 U.S. business days. Unlike a typical inspection, the list of observations may not be provided via a FDA 483.³ Postevaluation, FDA will also provide the facility with a copy of the evaluation report. Moreover, FDA notes that the final remote evaluation report and any written list of observations may be subject to disclosure under the Freedom of Information Act.

Regulatory Implications

The agency intends to use information from remote interactive evaluations to continue monitoring facilities covered by the Guidance and to meet its user-fee obligations. Even though remote interactive evaluations are not traditional FDA inspections and generally are not a replacement for traditional inspections, FDA may use the information and documentation obtained during these evaluations to support FDA’s assessment of pending product applications, including decisions about approval of a new drug or biologic, or to avoid the need to conduct a follow-up inspection for a reported issue. Additionally, FDA may use that information to justify a follow-up inspection or surveillance activity or to support a warning letter, recall activities, import alert, or other enforcement action. Moving forward, facilities should invest significant resources in carefully preparing for remote interactive evaluations. This is particularly important because the continued backlog of FDA facility inspections will likely lead to significant delays in follow-up inspections and the resolution of any enforcement action taken by the agency.

¹Due to the COVID-19 public health emergency, FDA published this as final guidance without prior public comment because the agency determined that prior public participation was not feasible or appropriate. However, the Guidance remains subject to comment in accordance with the agency’s good guidance practices.

²FDA, Guidance for Industry: Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities During the COVID-19 Public Health Emergency (issued April 14, 2021) (available at https://www.fda.gov/media/147582/download).

³Id. at 12. In a footnote, the Guidance explains that if the remote interactive evaluation is intended to supplement a scheduled inspection, FDA typically will include any observations from the remote interactive evaluation on a list of observations in the Form FDA 483 that is issued at the close of the inspection.