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The Prescription Drug User Fee Act (PDUFA), first enacted in 1992 and revised in 1997 and 2002, is a program under which the pharmaceutical/biotechnology industry pays certain "user fees" to the Food and Drug Administration (FDA). In exchange for these fees, the FDA agreed, via correspondence with Congress, to a set of performance standards intended to reduce the approval time for New Drug Applications (NDA) and Biological License Applications (BLA).
PDUFA assess three types of user fees: (1) fees on applications (NDA/BLA); (2) annual fees on establishments; and (3) renewal fees on products. The law includes a set of "triggers" designed to ensure that appropriations for application review are not supplanted by user fees. These triggers require that Congressional appropriations for such review reach certain levels before user fees may be assessed, and that the FDA devotes a certain amount of appropriated funds annually to drug review activities.
PDUFA IV
BIO Commends House for Approving PDUFA Reauthorization Package (September 19, 2007)
Read BIO press release
Testimony before the House Committee on Energy and Commerce, Health Subcommittee (April 17, 2007)
by Kay Holcombe, Senior Policy Advisor, Genzyme Corporation
Read the testimony (50 KB PDF)
Statement by BIO at FDA Public Meeting (February 16, 2007)
Read the statement (48 KB PDF)
Recommended Improvements to Prescription Drug User Fee Program Will Improve Drug Safety (January 11, 2007)
Read BIO press release
FDA Proposes New Measures to Strengthen Drug Safety Under PDUFA Reauthorized User Fee Program (January 11, 2007)
Read FDA press release
Statement by BIO at FDA Public Meeting (Nov 14, 2005)
Read the statement (48 KB PDF)
PDUFA III Implementation
Letter Expressing Appreciation for the Creation of the Independent Consultants Program.
Docket No. 03D-0112 (October 28, 2004)
Read the letter. (46 KB PDF)
Proposed Rule on Applications for Approval to Market a New Drug; Complete Response Letter; Amendments to Unapproved Applications
Docket No. 2004N-0267, Federal Register: July 20, 2004 (Volume 69, Page 43351) (October 18, 2004)
Read the comments.
BIO's final comments on FDA Draft Guidances on Risk Management
Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment. (July 2, 2004)
Read BIO's comments. (193 KB PDF)
BIO's final comments on FDA Draft Guidances on Risk Management
Development and Use of Risk Minimization Action Plans. (July 2, 2004)
Read BIO's comments. (119 KB PDF)
BIO's final comments on FDA Draft Guidances on Risk Management
Premarketing Risk Assessment. (July 2, 2004)
Read BIO's comments. (174 KB PDF)
BIO Comments on FDA's draft Guidance for Reviewers
On Providing Regulatory Submissions in Electronic Format - General Considerations. (Dec. 22, 2003)
Read BIO's comments (109 KB PDF).
BIO Comments on FDA's Statement of Work
For the Evaluation of First Cycle Review Performance. (Nov. 3, 2003)
Read BIO's comments.
BIO response to Risk Management Concept Papers (May 29, 2003)
Read BIO's response.
BIO's Comments regarding FDA's draft guidance
On Good Review Management Principles. (July 28, 2003)
Read BIO's comments (906 KB PDF).
BIO's comments regarding FDA's Guidance
For Industry on Independent Consultants for Biotechnology Clinical Protocols. (May 7, 2003)
Read BIO's comments (109 KB PDF).
PDUFA III Reauthorization
Summary of PDUFA Changes
Read the summary (225 KB PDF)
PDUFA Final Goals
Letter from HHS Secretary Tommy Thompson (June 4, 2002)
Read the letter (2.9 MB PDF)
House Passes Bioterrorism/PDUFA Legislation in 425-1 Vote
PDUFA Changes Minor; Bioterrorism Legislation 'A Good First Step' (May 22, 2002)
Read the press release
Testimony of Mary K. Pendergast, J.D., Executive Vice President, Elan Corporation
before the House Subcommittee on Health (Mar. 2, 2002)
Read the testimony
Statement of Michael Werner, Vice President for Bioethics
FDA Stakeholders Meeting (Dec. 7, 2001)
Read the statement
BIO President Addresses FDA on PDUFA (Sept. 18, 2000)
Read the press release
PDUFA Archive
Older materials on this subject are available in our archive.
Browse the Archive
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