In response to travel restrictions imposed during the COVID-19 pandemic, the U.S. Food and Drug Administration (“FDA”) began conducting remote regulatory assessments (“RRAs”) of medical products companies and other FDA-regulated establishments. The agency has continued using RRAs in the years since the pandemic, viewing them as a valuable complement to traditional, on-site inspections. On June 26, 2025, FDA released its final guidance for industry on RRAs entitled “Conducting Remote Regulatory Assessments: Questions and Answers” (the “Final Guidance”). The Final Guidance updates a January 2024 revised draft guidance and follows FDA’s issuance of two related draft guidances in 2023—“Alternative Tools: Assessing Drug Manufacturing Facilities Identified in Pending Applications” and “Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities”—which Ropes & Gray summarized in a prior Alert.
The Final Guidance largely mirrors the January 2024 draft guidance, providing clarity on the fundamentals of RRAs, FDA’s expectations during an RRA, the types of records and information that may be requested, and the actions FDA may take following an RRA. This Alert summarizes the key elements of RRAs and discusses how the new administration might use RRAs to support its manufacturing-related objectives, including the promotion of domestic pharmaceutical manufacturing.
Overview of RRAs
Types of RRAs. An RRA is a remote evaluation of an FDA-regulated establishment to assess compliance with applicable FDA requirements and to inform the agency’s regulatory decision-making and oversight activities. RRAs may take several forms, including requests for records and other information, read-only access to certain electronic databases, and remote interactive evaluations (e.g., livestreaming video of operations, teleconferences, and screen sharing).
Mandatory versus voluntary RRAs. RRAs may be either mandatory or voluntary. Mandatory RRAs include those conducted under Section 704(a)(4) of the Federal Food, Drug and Cosmetic Act (“FDCA”), which authorizes FDA to request records or other information in advance of or in lieu of a drug, device, or bioresearch monitoring inspection, and those of food importers subject to the Foreign Supplier Verification Program (“FSVP”) under Section 805 of the FDCA. Voluntary RRAs may be conducted following an establishment providing consent and are not mandated by statute or regulation (or when FDA elects not to exercise its mandatory authority in a certain instance).
RRAs versus inspections. FDA does not consider RRAs to be inspections. Inspections under Sections 704(a)(1) and 704(a)(5) of the FDCA generally involve FDA investigators physically entering establishments, whereas RRAs are conducted virtually. Furthermore, unlike for inspections, FDA does not issue a Form 482 (Notice of Inspection) prior to an RRA or a Form 483 (Notice of Inspectional Observations) following an RRA.
Follow-up from an RRA. The Final Guidance states that upon completion of an RRA, FDA “may” hold a closeout meeting with the establishment’s management to present and discuss a written list of RRA observations, if any. Even though an RRA is not technically an inspection, the RRA closeout process appears analogous to the closeout meeting and presentation of a Form 483 that occurs upon the conclusion of an inspection. FDA encourages establishments to submit written responses to RRA observations received at a closeout meeting within 15 business days, akin to the timeframe for responding to a Form 483. Additionally, the Final Guidance states that FDA will “ordinarily” prepare a written report summarizing the information reviewed, conditions and practices found, and any observations identified during an RRA, and will “in general” provide the establishment with the narrative portion of the report. This RRA report appears to be the equivalent of the establishment inspection report (“EIR”) that FDA creates following an inspection. RRA observations, an establishment’s written response, and FDA’s RRA report are subject to disclosure (with applicable redactions) under the Freedom of Information Act in the same manner as inspection-related materials.
Looking Ahead
While the Final Guidance addresses the mechanics of RRAs and what companies should expect when an RRA occurs, it notably does not address how FDA intends to utilize RRAs to advance the current administration’s broader policy objectives in the life sciences industry. These include promoting more domestic manufacturing of medical products and ensuring foreign manufacturing facilities receive the same level of oversight as domestic facilities.
How will RRAs be used to support the administration’s goals to encourage domestic pharmaceutical manufacturing? The administration has consistently emphasized an “America First” approach, as reflected in Executive Order 14293 issued on May 5, 2025, to “facilitate the restoration of a robust domestic pharmaceutical manufacturing base.” The Executive Order directs FDA to review existing regulations and guidance to, among other things, “streamline and accelerate the development of domestic pharmaceutical manufacturing.” FDA must “evaluate the current risk-based approach to prior approval of [sic] licensure inspections, including when such inspections are necessary, and seek to improve upon this approach to ensure all required inspections are prompt, efficient, and limited to what is necessary to ensure compliance” with the FDCA. Based on this directive, FDA may adjust its risk-based inspection approach such that fewer inspections are necessary to support FDA’s review of drug and biologic product applications for domestic manufacturing site changes and additions and instead rely to a greater extent on RRAs in these scenarios.
Will RRAs be used differently for foreign drug manufacturing facilities? Executive Order 14293 also calls for FDA to “develop and advance improvements to the risk-based inspection regime that ensures routine reviews of overseas manufacturing facilities involved in the supply of United States medicines.” Shortly after the issuance of the Executive Order, FDA announced plans to increase unannounced foreign inspections “to ensure that foreign companies will receive the same level of regulatory oversight and scrutiny as domestic companies.” In the announcement, Commissioner Makary asserted that foreign facilities “have enjoyed a double standard” because while inspections of domestic drug manufacturing facilities are generally unannounced, FDA historically has provided advance notice (i.e., a “pre-announcement”) to foreign facilities prior to an inspection for various logistical and practical reasons. Based on these developments, FDA appears poised to increase inspections of foreign drug manufacturing facilities. That could mean FDA will use RRAs less frequently with foreign facilities to the extent that FDA chooses to conduct an inspection instead of an RRA (which, by virtue of its remote nature, has to be preannounced). However, it could signal that FDA also intends to increase its use of RRAs with foreign facilities to ensure a greater proportion of foreign facilities are being assessed regularly through an inspection, an RRA, or both.
Will recent workforce reductions affect FDA’s use of RRAs? Although FDA investigators who conduct inspections have reportedly not been targeted by the agency-wide workforce reduction initiatives that have occurred since January, numerous support staff, including some responsible for arranging travel for inspections, were placed on leave. RRAs may provide FDA with a means to maintain or increase oversight activities while reducing the need for travel and other support personnel.
How will FDA publicize information regarding RRAs? Despite comments on the draft guidance requesting that FDA publish information about the use of RRAs, the Final Guidance does not specify how FDA will make information about RRAs publicly available. While FDA currently publishes a substantial amount of inspection-related data and information in various public databases, FDA does not currently publish any analogous data or information for RRAs. Consequently, FDA-regulated entities have little insight into the volume of RRAs conducted across the agency. Nor do they have visibility into the most common issues that FDA has identified during RRAs (which may or may not align with the most common issues that FDA identifies during inspections).
