FDA Updates Guidance on User Fee Waivers, Reductions and Refunds
The US Food and Drug Administration (FDA) on Wednesday issued a revised draft guidance providing recommendations to drugmakers planning to request a waiver or reduction in user fees for drugs and biologics.
The draft guidance updates the agency's 2011 final guidance User Fee Waivers, Reductions and Refunds for Drug and Biological Products and details the various types of fee waivers, reductions and refunds offered to industry such as those for pressing public health needs and when the fee would be a significant barrier to an applicant's ability to develop a drug.
FDA says the guidance has been updated to provide additional clarification on fee exemptions for orphan drugs and eligibility for fee waivers, reductions and refunds under the current statutory provisions.
The guidance also explains the criteria for small businesses looking to qualify for fee waivers and refunds for their first application for a human drug and includes a new section for the content and format of requests for small business waivers.