There are many educational events in FDA throughout the year that focus on the pharmaceutical and regulatory industries. One that combines both is the Regulatory Education for Industry (REdI) Annual Conference, and its most recent event took place on July 19–23, 2021. This complimentary conference offered three central tracks: drugs, devices, and biologics, gathering a lot of regulatory experts to discuss their field and provide a strong foundation in FDA’s regulatory requirements. The conference functions as an introductory course that leaves attendees with a clear understanding of the FDA’s processes and guidelines for the three tracks that it provides. (1)
This general plenary focused on the FDA and the emergency use Authorizations and other resources that make products available to the public in the face of the COVID-19 pandemic. The pandemic presented a public health emergency that required medical supplies products to be used in unapproved ways or even allow the use of unapproved products to protect life and treat diseases in the absence of alternatives. The plenary brought together the three directors of the FDA Center for Drug Evaluation and Research (CDER)， Center for Devices and Radiological Health (CDRH) and Center for Biologics Evaluation and Research (CBER), focusing each on their particular perspective. (2)
The conference was split into three tracks. A common theme was the impact of the COVID-19 pandemic on the three fields.
Drug Track
In regards to the drug track, there were several conferences throughout the event. The first one, by the director of the OND or Office of New Drugs who discusses the reorganization and restructuring of the OND and the New Drugs Regulatory Program Modernization. Another conference concerns the efforts of the CDER to modernize as well. The attendants were introduced to the CDER NextGen Portal, a cloud solution for drug standards, and to the use of the Electronic Common Technical Document (eCTD). There was a spotlight throughout several conferences on how different institutions have adapted to COVID-19, the use of emergency use authorizations for the drug field, as well as a concern with best practices and new drug development in pandemic times. There was a lot of concern with best practices for communication, regulation, and medical trials during this period of uncertainty when public health becomes especially important .(2)
Device Track
The device track focused on device regulations, how they worked, and how it was possible to speed the approval process through best practices. It introduced the Q-Submission Program, which provides applicants with the option to request feedback and meetings with the FDA throughout the product development and approval cycle. There were two conferences focused on the 510(k) Program, the most common pathway to market medical devices in the United States, considering the legal and practical issues involved. (2)
The conferences introduced the Bioresearch monitoring program or BIMO, run by the FDA, that inspects and audits data for devices, providing practical advice on what to expect from an inspection and how to make it more successful. (2)
Other important aspects that were addressed by the speakers involved CAPA or the Corrective and Preventive Action subsystem, the Manufacturer and User Facility Device Experience or MAUDE database that contains all the reports submitted to the FDA, Additive Manufacturing and the existing technology, and, finally, a detailed analysis of Class I and Class II recalls that have taken place to help manufacturers navigate the process. (2)
Biologics Track
The biologics track involved speakers discussing different aspects of manufacturing involving biological products. For instance, there was discussing of 21 CFR Part 1271 (known as the "Tissue Rule"): ...
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