Breaking Down FDA’s New Remote Monitoring Strategy

In April 2021, the US Food and Medications Administration (FDA) published a long-awaited final guidance document explaining its policy for conducting remote “evaluations” during COVID-19. According to the supervision, FDA will request and manage voluntary remote evaluations at

Facilities, where medications and biologics are manufactured, processed, packed, or, held;

Facilities covered below the bioresearch monitoring (BIMO) program; and

Outsourcing facilities are registered under section 503B of the Federal Food, Drug, and Cosmetic Act (FDCA). 

The evaluations do not refund in-person inspections, and FDA Form 483s will not be issued as a result of the inspection, but the results could be used to sustain regulatory actions, such as approving a pending product application. And in such cases, you need some experts like FDA lawyers.

Likely Candidates for Remote Interactive Evaluations

FDA has and proceeds to prioritize domestic facility inspections and inspections that are “mission-critical,” such as pre-approval inspections to promote products that have gained breakthrough therapy or regenerative advanced therapy designations, or other products used to treat severe diseases or medical conditions for which there is no suitable alternative.

FDA uniformly leads to its remote monitoring activities as “remote interactive evaluations,” in contrast to in-person “inspections.” FDA classifies five inspection categories that would be examined for remote interactive evaluations:

Pre-Approval and Pre-License Inspections, which are used to appraise a marketing application and ensure that distinguished facilities can perform the intended manufacturing operations in conformance with current good manufacturing practice (CGMP) requirements;

Post-Approval Inspections, which assess modifications to a drug’s manufacturing operations;

Surveillance Inspections, which examine overall regulations, including quality controls and CGMP agreement, and are often performed at active production facilities and 530B outsourcing facilities;

Follow-Up and Compliance Inspections, which petition specific medication quality problems or facility issues that come to FDA’s attention (g., product safety or quality concerns);

BIMO Inspections, which FDA uses to control FDA-regulated research accompanied under the BIMO program.

If FDA ascertains that a remote interactive evaluation is suitable for a particular purpose, it will confirm the relevant party’s willingness and ability to participate in a remote interactive evaluation, including the use of teleconference, Livestream video, and screen splitting of data and documents. If the company agrees, FDA will cooperate with the party to plan and organize the exercises for a remote interactive evaluation. FDA recommends that if the party does not agree, it could delay the legislative process.

Final Words

As currently volunteered, the guidance document will only remain in impact for the span of the COVID-19 public health emergency (PHE), as determined by the Secretary of Health and Human Services. Thus, post-pandemic connections are unclear; however, this new willingness to embrace technology-enabled tools to rig the FDA’s mounting accumulation may transform FDA’s investigation approach for intervals to come.

Notwithstanding the inventory backlog, it is dubious that in-person inspections will ever be fully denied because they enable unannounced analyses, provide a more holistic view of facility sanitation, and permit for real-time stability and analysis.

So, for such situations and cases, it will be really helpful and beneficial to go for the very experts an FDA attorney, who not only help you but also guides you for your services and assistance.