FDA issues final Guidance on Remote Oversight Tools

In September 2023, the FDA issued a new draft guidance document on the possible use of alternative methods in preparing for inspections or even in lieu of an inspection for pending marketing authorisation applications: "Alternative Tools: Assessing Drug Manufacturing Facilities Identified in Pending Applications".
The aim was to establish a risk-based approach to decision-making, e.g. when requesting additional documentation, conducting remote assessments or using information from other authorities.

According to the FDA, this was intended to achieve "operational flexibility" in order to facilitate the timely approval of medicinal products. These alternative tools complement inspections but are not considered as such.

Now the final guidance document was published. In finalising the document, the FDA also considered comments received after the draft was published. For example, adjustments and clarifications were made on the following points:

• Recommended timeframe for drug manufacturers to provide requested documentation
• Use of remote subject matter experts during inspections (timeframe, acceptance)
• Coordination of technologies
• Difficulties with virtual interactions