FDA Optimizes Remote Regulation Tools

The U.S. Food and Drug Administration (FDA) has released new draft guidance on the potential expansion of the agency’s remote regulatory assessments (RRAs), which arose during the COVID-19 pandemic in order to examine an establishment or records entirely remotely. The guidance released on July 22 detailed the FDA’s plans and some anticipated frequently asked questions that the agency addressed.

The FDA stated in their announcement that these new, optimized guidelines would allow the RRAs to become a tool that is “incorporated consistently across all FDA-regulated products” once finalized. The initial benefits outlined by the agency included using RRAs to determine compliance, inform regulatory decisions, and verify information submitted to the agency.

RRAs help protect human and animal health, according to the FDA. However, while the agency considers them a helpful tool, RRAs do not qualify as a full statutory inspection.

The FDA currently has two kinds of RRAs: voluntary and mandatory. Voluntary RRAs are FDA requests that a facility or company can opt into and participate of their own volition. Mandatory RRAs are issued to establishments that manufacture, prepare, propagate, compound, or process drugs or are subject to certain laws that give the FDA the authority to compel them to comply with an RRA.

In addition to promoting safety, the FDA guidance gives several detailed examples of how RRAs can assist the agency, industries, and the public. Some of the FDA’s examples include:

  • Remotely evaluating products, clinical studies, and establishments, increasing the speed with which corrective action can be taken against dangerous or deficient actors.
  • Using RRAs before a full inspection to reduce the resources expended during the formal inspection.
  • Verifying corrective actions taken in response to inadequacies detected during a previous inspection.
  • More easily examining foreign or international manufacturing facilities.

As a proof of concept, the FDA cited over 1,470 RRAs of domestic manufacturers and over 600 RRAs of foreign manufacturers performed over the last two years. The FDA claims that these RRAs identified unreported adverse events, gathered information about products that violated import alerts, evaluated marketing corrections by pharmaceutical and nutritional supplement companies, and enhanced the agency’s regulatory and premarket submission decisions.

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