|
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- Notice of Availability: Draft Guidance for Industry on User Fee Waivers for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The Draft Guidance [Word]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Draft Guidance for Industry and Food and Drug Administration Staff: Application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Draft Guidance (9/29/2004)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.
Back
to Top
Back to PDUFA
PDF requires the free Adobe
Acrobat Reader
Date created: January 31, 2007, updated August 1, 2008
|
|