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Q-Sub Guidance Needs Clarity On Informal Meetings And Timelines, Say Commenters

 
• By Brian Bossetta

Stakeholders say the US FDA’s Q-sub guidance could use some tweaking, especially for identifying when informal meetings with the agency are more appropriate than formal ones and creating less burdensome timelines.

Meeting Schedule
• Source: Shutterstock

The US Food and Drug Administration’s Q-Submission (Q-Sub) program offers device manufacturers a valuable service by giving them the opportunity to meet with the agency prior to submitting their devices for approval, according to AdvaMed. The trade group says these meetings can provide sponsors with the feedback necessary to guide product development, preparation of a marketing submission, and responses to requests for additional information.

However, the agency’s updated

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