FDA Publishes Final Rules for Alternative Tools in Drug Inspection Processes

In September 2023, the FDA released draft guidance on using alternative methods to prepare for inspections—or in some cases, as substitutes for inspections—of drug manufacturing facilities under pending marketing authorization applications. The guidance, titled “Alternative Tools: Assessing Drug Manufacturing Facilities Identified in Pending Applications,” aimed to implement a risk-based approach, allowing the agency to request additional documentation, conduct remote assessments, or leverage information from other regulatory authorities.

The goal is to provide operational flexibility while facilitating timely approvals, with alternative tools intended to complement, not replace, traditional inspections.

The FDA has now published the final guidance, taking into account feedback on the draft. Updates clarify recommended timeframes for submitting documentation, use of remote subject matter experts, technology coordination, and challenges associated with virtual interactions, providing clearer expectations for drug manufacturers and regulators alike.

27-09-2025