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FDA issues final guidance on using remote oversight tools to help approve drugs

FDA has issued a final guidance on how the agency intends to use alternative tools in advance, in lieu of, or in support of preapproval and prelicense inspections to remotely evaluate drug manufacturing facilities named in pending applications as part of FDA’s drug review process.

FDA uses a risk-based approach to determine if alternative tools are appropriate for use. These tools may include requesting records from manufacturers, conducting remote interactive evaluations of facilities, receiving information from foreign regulatory partners, collaborative inspections conducted by foreign regulators with FDA remote participants, and supporting PAIs and PLIs with FDA remote subject matter experts.

When finalizing the guidance, FDA considered comments received on the draft guidance issued in September 2023. Based on the comments received, FDA updated the guidance with clarification on: 

• a recommended timeframe for drug manufacturers to provide FDA with requested records
• timeframes for when FDA may request to use a remote subject matter expert during an inspection of a drug manufacturing facility
• FDA’s efforts to coordinate logistics and technologies with drug manufacturers
• the effect of a drug manufacturer declining to allow FDA to use a remote subject matter expert or of a manufacturer being unable to support the virtual interaction with FDA

This final guidance will help the agency maintain operational flexibility to support review of drug applications and facility evaluations, which could promote timely approval of drugs and facilitate the availability of new, generic, and biosimilar drugs for patients.

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