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US SMALL BUSINESS FEE REQUESTS

The US Prescription Drug User Fee Act (PDUFA) permits FDA to grant certain waivers and fee reductions from drug application fees under limited circumstances. Donawa Lifescience Consulting (DLC) can provide guidance on the requirements for waivers, reductions and refunds of fees and assist companies in obtaining small business status.

Small businesses are considered to be companies with 500 or fewer employees.

Please contact us for additional information and assistance.