Remote Regulatory Assessment Conducted for Industry Guidance by FDA
Considering the COVID-19 pandemic, the Food and Drug Administration (FDA) has introduced new guidelines and regulations to adapt to the changing landscape of the pharmaceutical industry. One significant development is the remote regulatory assessment (RRA) conducted for industry guidance by the FDA. This approach allows for conducting regulatory assessments remotely. This will result in minimizing physical interactions while maintaining the efficiency and effectiveness of the regulatory process. As already being reported, cases of RRAs are being used to identify unreported adverse events unreported events and incomplete corrective actions. We are going to discuss the remote regulatory assessment conducted for industry guidance by FDA in this blog.
The Need for RRA Conducting
The traditional regulatory assessment process usually involves in-person visits and inspections by FDA officials at pharmaceutical facilities. However, the pandemic has posed challenges in conducting these assessments due to travel restrictions, safety concerns, and the need to maintain social distancing measures. RRAs have also furnished details on substandard practices, prompting the FDA to take regulatory measures and conduct inspections. Additionally, they contribute to future inspection planning. RRAs have played a role in supporting the review process and facilitating the timely approval or authorization of marketing submissions for FDA-regulated products.
In the context of the food program, these have aided in evaluating compliance with veterinary feed directive regulations, scrutinizing foreign manufacturing process records, adding foreign establishments to import alerts, and issuing warning letters. Drawing from these experiences, the FDA has recognized the value of RRAs and advocates their continuation under specific circumstances. This assists the FDA in fulfilling its mission of safeguarding public health, overseeing regulated industries, and ensuring compliance with FDA requirements for various regulated products.
Regarding section 704(a)(4) of the FD&C Act, which was recently amended by the Food and Drug Omnibus Reform Act of 2022 (FDORA), the FDA is granted the authority to request (and establishments are obliged to provide) any records or information inspectable under section 704. This can occur before or instead of inspections for establishments engaged in manufacturing, preparing, propagation, compounding, or processing drugs or devices. It also applies to sites or facilities that are subjected to inspection under section 704(a)(5)(C), covering entities subject to bioresearch monitoring (BIMO) inspections. As a response to these challenges, the FDA has recognized the importance of conducting remote regulatory assessments to ensure the continuity of regulatory oversight while prioritizing public health and safety.
RRA Amendment Criteria
FDA believed in implementing both voluntary and mandatory submissions for all types of regulated products. In the interest of the public interest, the FDA issued notice on the classification for the mandatory and voluntary types of submission, as listed below:
Mandatory RRAs
Compulsory RRAs encompass examinations carried out for two specific categories. Establishments falling under Section 704(a) (21 U.S.C. 374(a)) empower designated officers or employees to inspect drug-related establishments, presenting credentials and written notice. The inspection covers factories, warehouses, and vehicles involved in interstate commerce.
For prescription and nonprescription drugs, the scrutiny extends to all pertinent elements, ensuring compliance with the Act. Courts affirm the legality of inspections if conducted reasonably in terms of time, limits, and manner, safeguarding against adulteration or misbranding of drugs intended for human use; and importers, as outlined in 21 CFR 1.500, who are subject to the Foreign Supplier Verification Program (FSVP) under section 805(d) of the FD&C Act and the relevant regulations in 21 CFR 1.510(b)(3) or 1.512(b)(5)(ii)(C), as appropriate. When commencing a mandatory RRA, the FDA aims to explicitly specify the legal authorities according to which the RRA is being requested.
Voluntary RRAs
If there is no statutory or regulatory mandate for an RRA, or if the FDA chooses not to exercise its mandatory RRA authority in a particular instance, the FDA may still ask any establishment (such as food producers, tobacco product manufacturers, drug or medical device manufacturers, clinical investigators, or others) to engage in a voluntary RRA.
Benefits of Remote Assessments
RRAs present several benefits for the FDA and the pharmaceutical industry.
Firstly, it reduces the need for physical presence, eliminating travel costs and time associated with on-site inspections. This can contribute to significant cost savings for the regulatory authority and the pharmaceutical companies.
Secondly, remote assessments offer greater flexibility in scheduling and conducting the regulatory process. As remote assessments can be conducted from different locations, it allows for better coordination between FDA officials and industry representatives. This flexibility enables more efficient use of resources, reducing delays in regulatory assessments.
Furthermore, remote assessments can increase the diversity of expertise involved in the process. With the ability to include specialists from different locations, FDA officials can collaborate with subject matter experts nationwide or internationally. This collaboration can lead to more comprehensive and robust assessments encompassing broader perspectives.
Ensuring Effective Remote Regulatory Assessments
To ensure the effectiveness and reliability of RRAs, the FDA has provided industry guidance outlining best practices and expectations. These guidelines emphasize the need for clear communication and coordination between the FDA and the pharmaceutical industry throughout the remote assessment process. To facilitate the assessment, pharmaceutical companies must provide detailed documentation, including Standard Operating Procedures (SOPs), data, and quality assurance records. Timely and open communication is crucial to address any queries or concerns during the assessment procedure. During remote assessments, FDA officials may rely on virtual tools such as video conferences, document-sharing platforms, and live streaming to conduct interviews, review documentation, and remotely inspect facilities. The technology ensures effective communication, transparency, and real-time interaction between FDA representatives and pharmaceutical companies.
Future Implications
Adopting RRA conducted by the FDA can revolutionize the regulatory landscape beyond the pandemic. The experience gained from implementing this approach during the crisis may lead to permanent changes in how regulatory assessments are conducted. The successful implementation of remote assessments during the pandemic demonstrates the adaptability and resilience of both the FDA and the pharmaceutical industry. As technology advances, remote assessment methods may become more sophisticated, enabling even more robust and comprehensive evaluations.
ConclusionÂ
In conclusion, the FDA’s industry guidance on conducting remote regulatory assessments has provided a framework for pharmaceutical companies to ensure regulatory compliance while prioritizing health and safety (for all parties involved). This approach has demonstrated the potential for increased efficiency, flexibility, and collaboration in the regulatory assessment process. The continued adoption and refinement of remote regulatory assessments have the potential to shape the future of the pharmaceutical industry’s regulatory landscape.
A link to the FDA draft guidance is presented below:
References:
- Newton W. Decentralized regulation: What do FDA remote assessments mean for sponsors? Clinical Trials Arena. Clinical Trials Arena. August 31, 2022. https://www.clinicaltrialsarena.com/features/remote-regulatory-assessments/.
- FDA describes plans to expand remote regulatory assessments. Regulatory Affairs Professionals Society (RAPS). July 22, 2022. https://www.raps.org/News-and-Articles/News-Articles/2022/7/FDA-describes-plans-to-expand-remote-regulatory-as.
- FDA Releases Final Guidance on Use of Digital Health Technologies for Remote Data Acquisition in Clinical Investigations. HYMAN, PHELPS & MCNAMARA & PC. FDA Law Blog (February 09, 2024), https://www.thefdalawblog.com/2024/02/fda-releases-final-guidance-on-use-of-digital-health-technologies-for-remote-data-acquisition-in-clinical-investigations/.
- The Future of Pharma Regulations. i-Pharm Consulting. February 04, 2023. https://www.i-pharmconsulting.com/blog/the-future-of-pharma-regulations/.
- Conducting Remote Regulatory Assessments—Questions and Answers; Draft Guidance for Industry; Availability (Docket ID: FDA-2022-D-0810). Federal Register/Vol. 89, No. 18/Friday, January 26, 2024/Notices. https://www.federalregister.gov/d/2024-01589.
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