FDA Issues Guidance on Remote Interactive Evaluations During COVID

FDA recently issued guidance on remote interactive evaluations of drug facilities where COVID-19 drugs are manufactured, processed, packaged, and held during the pandemic.  

As part of the guidance, FDA may request to conduct a remote interactive evaluation whenever a program office determines it is appropriate based on needs and accessibility. 

“FDA conducts inspections for many purposes and programs, and we will consider each of those inspection program areas as possible candidates for a remote interactive evaluation,” the agency said in the guidance. 

The inspections include pre-approval inspections (PAIs), pre-license inspections (PLIs), post-approval inspections (PoAIs), surveillance inspections, follow-up and compliance inspections, and bioresearch monitoring (BIMO) inspections. 

FDA will consider each of the areas as potential candidates for remote interactive evaluation.

The second part of the guidance focuses on selecting a facility.

FDA will apply risk management methods and tools to determine when to request a facility’s participation.

Specifically, the agency could request a facility’s records, which could minimize risk associated with conducting inspections during the pandemic. 

When FDA determines that a remote interactive evaluation is appropriate, it will notify a facility and request confirmation from the facility of its willingness and ability to participate. 

If the facility agrees to remote interactive evaluation, it then will need to confirm the point of contact for the evaluation, facilitate planning, and determine its ability to transfer records and perform remote interactions with FDA staff.

FDA will also schedule a virtual meeting to discuss logistics, responsibilities, and expectations.

These meetings will include topics such as the objectives of the remote interactive evaluation, introduction of FDA remote interactive evaluation team, schedule of virtual interactions and anticipated duration of the evaluation, and FDA’s expectations during the walkthroughs of the facility.

Additionally, FDA will discuss time zone differences and translation services, methods for sharing information, and technological limitations that could prevent remote interactive evaluation at the facility.

For the technological component of the evaluation, the quality of the remote connections should be adequate for FDA to review, observe, examine, and evaluate the information needed. 

The technologies should also allow access for remotely viewing and evaluating operations at the facility as necessary. These operations include aseptic practices, equipment cleaning, material dispending, instrument set up, sampling, and testing. 

When facilities agree to participate in a remote interactive evaluation, FDA stated that it expects them to “cooperate with the same level of transparency as they would during an FDA inspection.”

As part of the evaluation, FDA may request and review documents, use livestream or pre-recorded video to examine facilities, schedule interviews to address questions or concerns, evaluate a facility’s corrective actions, and provide updates to the facility on any issues observed.

Once a remote interactive evaluation is complete, FDA will hold a meeting with the facility’s management and present a written list of detailed observations to enable overall understanding. 

The information documented could help to support FDA’s assessment of pending applications, preclude the need for an inspection in follow-up to a reported concern, support a regulatory meeting, prioritize a facility for inspection, or justify a follow-up compliance inspection. 

The use of remote interactive evaluations should help FDA operate within normal timeframes, especially for higher priority activities despite challenges related to the COVID-19 pandemic. 

If a facility declines to participate in a remote interactive evaluation, it could hinder FDA’s ability to make a timely regulatory decision, the agency said. 

This guidance will remain in effect for the duration of the public health emergency related to COVID-19.