Search Results for prescription drug user fees

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PDUFA VI: FDA Explains User Fee Changes in Draft Guidance By Zachary Brennan - Published 12 October 2017

The US Food and Drug Administration (FDA) has begun implementing the Prescription Drug User Fee Amendments of 2017 (PDUFA VI) and on Thursday released draft guidance explaining the new fee structure and types of fees for which industry is responsible.

Categories: News, US, FDA, Drugs, Government affairs, Submission and registration

Tags: PDUFA VI, prescription drug user fees, draft guidance

HHS Inspector General Finds FDA Spends User Fees Appropriately By Zachary Brennan - Published 05 October 2017

The US Department of Health and Human Services’ (HHS) Office of Inspector General on Thursday released a report finding that the Food and Drug Administration (FDA) generally spent prescription drug user fees appropriately.

Categories: News, US, FDA, Compliance, Drugs, Government affairs

Tags: HHS OIG, user fee expenses, prescription drug user fees