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The final say
November 2019
SHARING OPTIONS:

BETHESDA, Md.—The U.S. Food and Drug Administration (FDA) announced last month that it had finalized its guidance regarding Prescription Drug User Fee Act (PDUFA) fee waivers, reductions and refunds. The draft for this guidance was released for public comment in June of 2018, serving as an update for the previous guidance released in 2011. Explained within are the waivers, reductions and refunds offered, including those for urgent public health needs, small business entities and cases when the fee would significantly inhibit an applicant’s ability to develop and bring a drug to market. The guidance also stipulates a deadline for requesting a fee refund: 180 calendar days from the date said fee is due.

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