Remote regulatory assessments: Pharma, device groups want more details on FDA guidelines

Remote regulatory assessments: Pharma, device groups want more details on FDA guidelines

Regulatory newsRegulatory news

| September 28, 2022 | By Joanne S. Eglovitch

Trade groups representing the pharmaceutical and medical device industries, while broadly supporting the use of remote regulatory assessments (RRAs) as outlined in recent draft guidance from the U.S. Food and Drug Administration (FDA), are asked how these assessments would work in practice, including how they would coordinate with on-site inspections, whether they can be leveraged by foreign regulators, and how the FDA plans to ensure the confidentiality of companies and personnel subject to release live.

While the FDA has been conducting assessments remotely since the start of the pandemic, its guidance, when finalized, would formalize its plan to use those assessments to supplement on-site inspections as it exits crisis response mode. pandemic. The draft guidelines were published in May. (RELATED: FDA outlines plans to expand remote regulatory reviewsRegulatory guidanceJuly 22, 2022)

The agency received 26 comments on the guidance, with responses from a wide range of medical device and pharmaceutical groups, as well as consumer groups and the food industry.

PhRMA: More information needed on coordination of on-site and remote inspections

The Pharmaceutical Research and Manufacturers of America (PhRMA) wants clarity on how RRAs would be coordinated with on-site inspections to avoid duplication of effort.

“The PhRMA largely agrees with the benefits of RRAs that the FDA cites in the draft guidance. However, the PhRMA strongly encourages the FDA to address, in the draft guidance or otherwise (eg, MAPP, SOPP), the Agency’s process for internal coordination on RRAs. For example, we recommend that FDA establish internal procedures to ensure that, in the event of an on-site inspection following an RRA, inspectors have access to information previously collected as part of the RRA. Greater transparency across the FDA will help realize benefits for the FDA and biopharmaceutical companies by reducing duplication of effort.

The group also wanted clarification on how RRAs could be operated by foreign inspections instead of on-site inspections.

“While we recognize that RRAs are not inspections, we nevertheless believe that it would be helpful if the FDA explained how RRAs might be operated by foreign regulators, such as recognized competent regulatory authorities under mutual regulatory agreements. This will help foreign regulators consider FDA RRAs when conducting oversight activities, which in turn will help foster an overall effective approach to manufacturing oversight.

The PhRMA also urged the FDA to extend the 15-day deadline for responding to observations noted in an RRA.

AAM: Can RRAs be used to close warning letters?

The Association for Accessible Medicines (AAM) has suggested that the FDA clarify whether RRAs can be used to reclassify a facility from Official Action Indicated (OAI) status to compliant status or whether they can be used to close a letter. of warning.

“AAM believes that RRAs can be a valuable tool for the FDA to determine whether it is appropriate to reclassify a facility from OAI status or to close a warning letter. The FDA indicates in the draft Q&A RRA guidelines that the Agency may use RRAs to reclassify a facility’s status or to close a warning letter, but this is not necessarily specified.

Device groups want clarification on benefits of RRAs, inspection schedules

The AdvaMed (Advanced Medical Technology Association) has urged the FDA to better embellish the benefits of RRAs.

AdvaMed stated that “FDA should highlight throughout the document the potential benefits of less frequent or reduced inspection duration/scope for RRA participants. We ask the FDA to include language in several instances in the document indicating the possible benefits of participating in the RRA in terms of reducing the frequency, scope, and duration of inspections. Reviewing participation in an RRA can be integrated into the FDA’s risk-based inspection program and lead to less frequent inspections at a facility, reduced time spent at the facility, and/or reduced scope of inspection.

The group also wants the FDA to clarify who has the authority to request an RRA as well as the mechanism for tracking RRAs within the agency.

The Medical Device Manufacturers Association (MDMA) wants clarity on how RRAs will feed into the FDA’s risk-based inspection schedule.

MDMA writes that “it is unclear how the FDA will use RRA to determine a site’s risk class status to plan future inspections. Additionally, MDMA believes that FDA should clarify how it intends to use RRAs with facilities that participate in the Medical Device Single Audit Program (MDSAP) or other programs that FDA recognizes in lieu of an inspection. We would also appreciate information on how the FDA plans to work with MDSAP auditors to share information generated by an RRA.

MDMA also said that certain terms in the guidelines appear to be used inconsistently throughout the guidelines. For example, terms such as “observations”, “concerns” and “potential violations” are “used inconsistently”.

PDA and BIO: Want more information on using live video

The Parenteral Drug Association (PDA) and the Biotechnology Innovation Organization (BIO) requested that the final guidelines add text to acknowledge how video recording personnel during RRAs will comply with country- and region-specific privacy regulations, such as than the EU General Data Protection Regulation. (GDPR).

The draft guidelines allow the use of live or pre-recorded video feeds to review facilities, operations, data and information.

BIO wrote that the final guidelines should include “recommendations on how to maintain the confidentiality of personal and proprietary information during live streaming.”


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