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US FDA’s Assessment Aid May Spell The End Of Dueling Advisory Committee Briefing Packages

 
• By Sue Sutter

Pilot project allows FDA conclusions about a drug’s efficacy and safety to be integrated with, but distinguished from, a sponsor’s own analysis; though currently used for reviews of oncology applications, template could become the basis for a consolidated advisory committee briefing document.

The US FDA’s Assessment Aid (AAid) pilot project resulted from a desire to reduce the amount of word processing oncology reviewers do as they analyze drug applications, but it also could spur a change in how FDA and sponsors put together briefing documents for advisory committee meetings.

The AAid is a voluntary submission by an applicant to facilitate FDA’s assessment of a new drug application (NDA) or biologics license application (BLA), including supplements

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