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Prescription Drugs › Orphan Drugs › PDUFA

Akin Gump Strauss Hauer & Feld LLP

FDA Continues Focus on Rare Disease Drug Development, Announces Evidence Principles

Akin Gump Strauss Hauer & Feld LLP on

On September 3, 2025, the Food and Drug Administration (FDA) announced Rare Disease Evidence Principles (RDEP) with processes aimed at providing greater predictability and facilitating the development and review of drugs...more

Wilson Sonsini Goodrich & Rosati

FDA Issues Final Guidance on PDUFA Waivers, Reductions, and Refunds

Wilson Sonsini Goodrich & Rosati on

The Prescription Drug User Fee Act of 2017 (PDUFA VI) authorizes the U.S. Food and Drug Administration (FDA) to assess fees (PDUFA fees) when applicants submit new drug applications (NDAs). PDUFA fees are substantial. For...more

Hogan Lovells

There'll Be Some Changes Made: President Signs Prescription Drug and Biologic User Fee Reauthorization Act

Hogan Lovells on

On August 18, 2017, President Trump signed into law the FDA Reauthorization Act (FDARA). FDARA reauthorizes user fees paid to FDA to support regulatory review of innovator drugs and biologics, medical devices, generic drugs,...more

Arnall Golden Gregory LLP

Money for Nothin': FDA's PDUFA Fee Waivers and Exemptions

Arnall Golden Gregory LLP on

Lately, we have received a number of client inquiries about prescription user fee waivers. The Prescription Drug User Fee Act (PDUFA), enacted in 1992, authorizes FDA to collect fees from companies that produce certain human...more

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