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2002 2001
2000 1999
1998 1997
1996
| 2002 Meetings
(link to transcripts and other
meeting information) |
Date: 11/18/2002-11/19/2002 (Joint meeting with the Peripheral
and Central Nervous System Drugs Advisory Committee)
Topic: On November 18, 2002, the committee will discuss the role of
brain imaging as an outcome measure in phase 3 trials of putative
therapeutic drugs for Alzheimer's disease; the discussions will not focus on
specific drugs or on specific applications to the agency. The agency is
considering whether brain imaging modalities can be utilized as surrogate
markers; that is, as primary outcomes in definitive clinical trials to
measure drug effect in lieu of clinical outcomes. The committee will
specifically discuss the following issues in reference to each imaging
modality: 1. How is the surrogate imaging modality best validated? 2. If one
uses an imaging modality to support a disease-modifying effect claim, how
does one establish that such an effect occurs? 3. Has any surrogate imaging
modality been validated at the present time? 4. Even if no surrogate imaging
modality has currently been validated, is it appropriate to use one or more
such modalities as primary or ancillary outcome measures of efficacy in
phase 3 clinical trials?
On November 19, 2002, the committee will consider a
supplemental new drug application (NDA) 20-306 for F-18 fluorodeoxyglucose (FDG)
positron emission tomography (PET) imaging proposed to diagnose and/or
identify progression of Alzheimer's disease and other forms of dementia.
This application is based on published multi-center controlled clinical
trials, additional information provided by some of the literature authors,
and other supportive literature. Considerations will include the relevance
of current practice, knowledge of Alzheimer's disease process, and clinical
trial design to establish clinical usefulness of F-18 FDG PET in Alzheimer's
disease. (Downstate Medical Center, Peoria, IL, is the sponsor of the new
drug application. The Academy of Molecular Imaging provided the literature
references and the literature summary that formed the basis of the
supplemental NDA.)
No meetings to date
| 2000
Meetings (link
to transcripts and other meeting information) |
Date: 7/10/00
Topic: Leutech (technicium labeled TC99M anti/CD15 antibody injection)
| 1999
Meeting (link
to transcripts and other meeting information) |
Date: 6/28/99-6/29/99
Topic: Presentation of findings on safety and effectiveness of three PET
drugs: Fludeoxyglucose F18 Injection, Ammonia N13 Injection, and Water O15 Injection
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| 1998
Meeting (link
to transcripts and other meeting information) |
Date: 2/9/98
Topic: AcuTect (NDA 20-887)
Document Available: Transcript
Additional Documents: Agenda, Materials
| 1997
Meeting (link
to transcripts and other meeting information) |
Date: 4/28/97
All 1996
transcripts can be ordered from the Freedom of Information Office
Date: 7/22/96-7/23/96
Topic: Prostascint (radiolabeled nonoclonal antibody), PLA 95-0041
Topic: Discussion and drafting of a "Points to Consider Document for
Developing Medical Imaging Agents"
Date: 2/15/96-2/16/96
Topic: Discussion and drafting of a Points to Consider for developing Medical
Imaging Agents.
Topic: Immu-4 (murine monoclonal antibody fragment directed against the
carcinoembryonic antigen), BLA 91-0209
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Human Drug Advisory Committee Information
Last Updated: November 26, 2002
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