FDA Spells Out Options for PDUFA Waivers

Drug and biologics sponsors seeking user fee waivers or reductions can request them in one of three categories, according to a revised draft guidance from the FDA.

The revised guidance is largely unchanged from the agency’s 2011 guidance, but the new draft adds a section on content and formatting for small business waiver requests.

The guidance states that the FDA will grant a waiver or reduction of one or more user fees if that is necessary to protect public health; if the assessment would hurt innovation due to the sponsor’s limited resources; or if the applicant is a small business submitting its first human drug application.