Industry wants to avoid surprises in remote regulatory assessments

As the US Food and Drug Administration (FDA) refines its guidance for conducting remote regulatory assessments (RRAs), industry is seeking assurances that the agency will provide advance notice for mandatory assessments and discuss observations before taking regulatory action.

In public comments on the FDA’s revised draft guidance on RRAs, industry members generally praised the continued use of remote assessments but called on the agency to provide more specifics on implementation.

The revised draft guidance, which was issued in January 2024, is written in a Q&A format and covers how the agency may initiate an RRA, what to expect during a remote assessment, what records may be requested and what happens after an RRA.

The latest guidance takes into account public comments on an earlier draft and incorporates provisions of the Food and Drug Omnibus Reform Act of 2022 that make more establishments subject to mandatory records requests. (RELATED: FDA updates guidance on remote regulatory assessments, Regulatory Focus 29 January 2024)

Mandatory versus voluntary

The Pharmaceutical Research and Manufacturers of America (PhRMA) asked the agency to add language in the guidance about providing an opportunity for discussion in advance of mandatory RRAs, ensuring that any record requests are “appropriately tailored” and outlining how the agency will provide feedback after the review of submitted records.

PhRMA also asked the agency to clarify that making experts available during an on-site inspection is not considered an RRA. Though the draft guidance states that the agency does not plan to conduct on-site inspections and RRAs simultaneously, a separate draft guidance (“Alternative Tools: Assessing Drug Manufacturing Facilities Identified in Pending Applications”) refers to making remote personnel available to on-site FDA inspection teams.

The Advanced Medical Technology Association (AdvaMed) recommended that FDA clarify that when it comes to devices, RRAs are only mandatory when they relate to document requests. Other RRAs that include activities such as teleconferences or livestreaming should be considered voluntary, according to AdvaMed. “FDA should include an unambiguous statement differentiating between mandatory and voluntary RRAs. Addition of a clear statement will avoid confusion among the regulated industry and help FDA investigators and Center staff with continuity and consistency,” AdvaMed wrote.

Final reports

PhRMA also applauded FDA for including language in the draft about making reasonable efforts to discuss observations with establishments to avoid surprises and misunderstandings. “We recommend FDA explicitly state that it intends to hold these discussions before FDA uses an RRA to take regulatory action,” PhRMA wrote in comments to the FDA.

AdvaMed asked FDA to issue a formal, written report at the conclusion of an RRA for devices. “The company needs a written report to adequately understand the Agency’s issues and be able to fully respond to the issues noted. The issuance of a written report will assist a company with endeavors to continuously improve in an efficient/timely manner,” AdvaMed commented.

The Association of Clinical Research Organizations (ACRO) also called on FDA to commit to providing feedback after an RRA, either through final reports or a close-out meeting. “ACRO believes that verbal feedback and written summaries are important information for the establishment that has undergone an RRA,” ACRO commented. “We ask the Agency to consider [taking] a stronger stand on these kinds of feedback to industry – perhaps by providing a very narrow set of circumstances where this feedback would not be provided and/or giving the establishment an opportunity to request a close-out meeting and/or written report when it is not provided by FDA.”

Foreign inspections

When it comes to inspections by foreign regulatory partners, PhRMA asked FDA to revise the guidance to note that it will only conduct voluntary RRAs during foreign oversight activities.

The Association for Accessible Medicines (AAM) also called on FDA to provide clarification related to RRAs and foreign inspections to avoid confusion. Specifically, AAM asked FDA how it will document its observations, whether these notes/reports would be subject to Freedom of Information Act requests, and if the agency will pose questions during foreign oversight activities. AAM suggested that FDA either provide additional details in a subsequent draft of the guidance or drop the concept from the RRA guidance and issue a separate white paper or guidance.

Transparency around RRAs

The Biotechnology Innovation Organization (BIO) asked FDA to explain how RRAs would be conducted under Mutual Recognition Agreements, specifically whether the findings from RRAs would be shared with other health authorities.

BIO also called on FDA to report that RRAs has been conducted as a way to show that establishments have undergone FDA oversight. For example, FDA could update current Good Manufacturing Practices (cGMP) declarations to include RRAs. This would strengthen the benefits of RRAs for industry, BIO wrote.

Comments on RRA Guidance

Industry wants to avoid surprises in remote regulatory assessments

Related topics

Recommended content

Welcome to the new RAPS Digital Experience