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PDUFA Guidance Documents
- Attachment D - Application, Product, and
Establishment Fees: Common Issues and Their Resolution, Revised December 16, 1994
- Submitting Separate Marketing Applications and Clinical Data
for Purposes of Assessing User Fees. [Text]
[PDF] (1/3/2005)
- Attachment F - Interim Guidance on Applicability
of User Fees to (1) Applications Withdrawn Before Filing, or (2) Applications the Agency
Has Refused to File and That Are Resubmitted or Filed Over Protest, July 12, 1993
- Notice of Availability: Guidance for Industry on
User Fee Waivers for FDC and Co-Packaged HIV Drugs for PEPFAR Final Guidance
[PDF]. (Posted 2/7/2007)
- Attachment G - Draft Interim Guidance Document for
Waivers of and Reductions in User Fees, July 16, 1993 (Posted 5/13/99)
- Draft Prescription Drug User Fee Act (PDUFA) IV Information Technology Plan [Text] [PDF]
(Posted 1/4/2008)
- Classifying Resubmissions in Response
to Action Letters, May 14, 1998
- Continuous Marketing
Application (CMA) Pilot Programs (Posted 3/9/2004)
- Fees-Exceed-The-Costs Waivers Under the Prescription Drug User
Fee Act, June 1999 (Posted
8/25/99) (addendum FY 2007 standard costs chart). [HTML] [PDF] (Updated 2/13/2009)
- Guidance for Industry and FDA Staff: Application User
Fees for Combination Products. Federal Register notice [TXT]
[PDF] (5/3/2005)
- Formal Meetings With Sponsors and Applicants for PDUFA Products [HTML] or [PDF]
(Issued 2/2000, Posted 3/6/2000)
- Good Review Management Principles
for PDUFA Products. [Text] or [Word] or [PDF]
(Posted 4/11/2005)
- Submitting and Reviewing Complete
Responses to Clinical Holds, May 14, 1998 [HTML]
or [PDF]
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Date created: February 4, 2008; Date updated: February 13, 2009 |
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