As the pandemic continues, the US Food and Drug Administration will rely selectively on virtual site visits to help it make timely approval and licensing decisions, though usually not to confirm post-warning letter corrective actions, the agency said 14 April in eagerly awaited guidance on what are generically called virtual inspections, but which it terms “remote interactive evaluations.”
The ability to make decisions based on remote interactive evaluations is an important tool that counterparts like the European Medicines Agency and the UK Medicines and Healthcare products Regulatory Agency have been using since early in the pandemic
KEY POINTS
Don’t call us, we’ll call you. Facilities must be prepared to host remote interactive evaluations if the FDA requests them, and that includes being ready to interact with the agency’s technology platforms and having a strong wi-fi signal throughout the facility, even in those trouble spots they might wish investigators would pass by.
A commitment to new products. The FDA will use remote evaluations to help meet user fee commitments for regulatory reviews.
Data integrity caveat. You may not get the call if your plant has demonstrated poor data integrity
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