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PDUFA Federal Register Documents
- Establishment of Prescription Drug User Fee Rates for Fiscal Year 2009 [Text] [PDF] (Posted 7/31/2008)
- Notice of Availability: Draft Prescription Drug User Fee Act IV Drug Safety Five-Year Plan [Text] [PDF] (Posted May 5, 2008)
- Draft Prescription Drug User Fee Act (PDUFA) IV Information Technology Plan [Text] [PDF]
(Posted 1/4/2008)
- Establishment of Prescription Drug User Fee Rates for Fiscal Year 2008 [Text] [PDF] (Posted 10/15/2007)
- Prescription Drug User Fee Act; Public Meeting, February 16, 2007
[Text] [PDF] (Posted 1/11/2007)
- Establishment of Prescription Drug User Fee Rates for Fiscal Year 2007. [Text] [PDF]
(Posted 8/2/2006)
- Prescription Drug User Fee Act; Public Meeting [Text]
[PDF]
(10/18/2005)
- Establishment of Prescription Drug User Fee Rates for Fiscal Year 2006. [Text]
[PDF]
(Posted 8/1/2005)
- Notice of Availability: Guidance for Industry and Food and Drug
Administration Staff: Application User Fees for Combination Products
[Text]
[PDF].
The Final Guidance [PDF]
(5/3/2005)
- Notice of Availability: Draft Guidance for Industry on User Fee Waivers for
FDC and Co-Packaged HIV Drugs for PEPFAR [Text]
[PDF].
The Draft Guidance [Word]
[PDF]
(Posted 4/19/2005)
- Notice of Availability: Guidance for Industry on Good Review Management
Principles for PDUFA Products. [Text]
[PDF]
The Final Guidance [Text] or [Word] or [PDF]
(Posted 4/11/2005)
- Notice to Industry on the Development of a
Web-Based System for Obtaining a User Fee Payment Identification Number and
Prescription Drug User Fee Cover Sheet (FDA Form 3397); Availability. [Text]
[PDF]
(3/10/2005)
- Notice of Availability: Guidance for Industry on Submitting Separate
Marketing Applications and Clinical Data for Purposes of Assessing User
Fees. [Text]
[PDF] The
Final Guidance [Text]
[PDF]
(1/3/2005)
- Notice of Availability:
Draft Guidance for Industry and Food and Drug Administration Staff: Application
User Fees for Combination Products. [Text]
[PDF] The
Draft Guidance
 (9/29/2004)
- Establishment of Prescription Drug User Fee Rates for Fiscal Year 2005. [Text]
[PDF]
(Posted 7/30/2004)
- Statement of Work for the Evaluation of First Cycle Review Performance,
Availability. [Text] [PDF] (Posted 10/21/2003).
- Sample Statement of
Work for the Evaluation of First Cycle Review Performance. [Word]
[PDF] (10/21/2003)
-
Establishment
of Prescription Drug User Fee Rates for Fiscal Year 2004. [Text]
[PDF]
(Posted 8/1/2003)
-
Establishment
of Prescription Drug User Fee Rates for Fiscal Year 2003. [Text]
[PDF]
(Posted 8/2/2002)
-
Establishment
of Prescription Drug User Fee Rates for Fiscal Year 2002. [Text]
[PDF] (Posted
1/14/2002)
-
Prescription Drug User Fee Act (PDUFA); Public Meeting;
Correction. [Text] [PDF]
(12/4/2001)
-
Prescription Drug User Fee Act (PDUFA); Public Meeting
Notice. [Text]
[PDF] [FDA
PDUFA Meeting Page] (11/21/2001)
-
Establishment of Prescription Drug User Fee Rates for
Fiscal Year 2001. Pages 79107-79111 [FR Doc. 00-31949] [Text]
[PDF]
(12/18/2000)
-
Establishment of Prescription Drug User Fee Rates for Fiscal Year 2000
(64 FR 72699, December 28, 1999) [Text]
[PDF]
-
Establishment of Prescription Drug User Fee Rates for Fiscal Year 1999
(63 FR 70777, December 22, 1998) [Text]
[PDF]
-
Establishment of Prescription Drug User Fee Rates for Fiscal Year 1998
(62 FR 64849, December, 9, 1997) [Text] or [PDF]
-
Establishment of Prescription Drug User Fee Rates for Fiscal Year 1998,
Correction (62 FR 67878, December 30, 1997) [Text] or [PDF]
- Delegations of Authority and Organization; Office of the Commissioner and the Center for
Drug Evaluation and Research (64 FR 59617, November 3, 1999) [HTML]
or [PDF] (11/19/1999)
Note: This
notice transfers the waiver program to CDER. It also has the address where waiver requests
can be submitted.
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Date created: January 31, 2007, updated August 1, 2008
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