USFDA Q&A Guidance: Remote Regulatory Assessments (RRA) and Guidance on Antibacterial Therapies (Q&A) and Early Lyme Disease

The U.S. Food and Drug Administration (FDA) has finalized its guidance document on "Conducting Remote Regulatory Assessments (RRAs)," marking a significant shift in the agency's approach to regulatory oversight. This new guidance, effective as of June 2025, solidifies the FDA's use of remote assessments as a permanent tool for gathering information from regulated establishments.

Conducting Remote Regulatory Assessments: Questions and Answers

What is a Remote Regulatory Assessment?

A Remote Regulatory Assessment (RRA) is a review of records and other information requested by the FDA and submitted electronically by a regulated entity.

The guidance clarifies that an RRA is a distinct activity and is not considered an inspection. It serves as a flexible and efficient tool for the FDA to fulfill regulatory purposes, such as preparing for an on-site inspection, conducting a follow-up after an inspection, or resolving a specific issue.

Key Takeaways from the Guidance

• Scope of Application: RRAs can be used for both pre-approval and post-approval assessments of various entities, including manufacturers, packagers, laboratories, and other establishments under FDA's jurisdiction. This flexibility allows the FDA to tailor its oversight to different situations, making the process more efficient.

• Requesting Records: The FDA will issue a written notice specifying the records required for the RRA and the deadline for submission. Firms are expected to submit these records electronically. The guidance highlights that the FDA can use the RRA authority to request and review records in place of, or in preparation for, an on-site inspection.

• Not a Substitute for Inspections: While an RRA can be used to gather information, it does not replace the FDA's authority to conduct an on-site inspection. The FDA may still decide to conduct a physical inspection after a remote assessment, depending on the findings.

• Outcomes and Communication: Based on the information gathered during an RRA, the FDA may issue an FDA Form 483 (Inspectional Observations) if the assessment reveals significant issues. The final RRA report will be provided to the establishment after the assessment is closed.

  
  

For more details, you can refer to the official FDA guidance document:

Conducting Remote Regulatory Assessments: Questions and Answers

Also, there were 2 recently updated (final) guidances

1. Antibacterial Therapies for Patients With an Unmet Medical Need for the Treatment of Serious Bacterial Diseases – Questions and Answers

   This guidance assists in the clinical development of new antibacterial drugs to treat serious bacterial diseases in patients with unmet medical needs, including patients with a serious bacterial disease for which effective antibacterial drugs are limited or lacking.

2. Early Lyme Disease as Manifested by Erythema Migrans: Developing Drugs for Treatment

   The purpose of this guidance is to assist sponsors in the clinical development of drugs for the treatment of early Lyme disease as manifested by erythema migrans (EM).