Drugs

Covid Remote Interactive Drug Facility Evaluation Guidance

FDA has published an immediately effective guidance describing how the agency will request and conduct remote interactive evaluations at facilities where drugs are manufactured, processed, packed, or held; facilities covered under FDA’s bioresearch monitoring program; and outsourcing facilities registered under section 503B of the Federal Food, Drug, and Cosmetic Act during the Covid-19 public health emergency. The document includes Introduction, Background, Planning a Remote Interactive Evaluation, Conducting a Remote Interactive Evaluation, Concluding a Remote Interactive Evaluation, and Impacts of Remote Interactive Evaluations on Established Commitments and Timeframes.

The document describes how remote interactive evaluations will be requested and conducted for the duration of the COVID-19 public health emergency at any facility where pharmaceutical products, including biological products, are manufactured, processed, packed or held. “FDA will use existing risk management methods and related tools to determine when to request a facility’s participation in a remote interactive evaluation,” an agency notice says.

FDA says it intends to use information from remote interactive evaluations to meet user fee commitments and to update facilities information. “Facilities can choose to decline FDA’s request to perform a remote facility evaluation; however, this may impede our ability to evaluate the facility or product and make a timely regulatory decision,” it says.

Acting commissioner Janet Woodcock was quoted as saying: “We recognize that remote interactive evaluations do not replace inspections, and that there are situations where only an inspection is appropriate based on risk and history of compliance with FDA regulations. Within the exceptional context of a global pandemic, we see remote interactive evaluations as part of a necessary strategy to evaluate medical product facilities by using all available approaches to ensure the medical products we regulate are safe, effective and of high quality.”

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