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| February 24, 1997 | August 18, 1997 | November 17, 1997 | May 11, 1998 | August 17-18, 1998 |
| May 17, 1999 | December 16, 1999 |
(Complete transcript is available at http://www.fda.gov/ohrms/dockets/ac/97/transcpt/3262t1.pdf.)
Open Public Session
This portion of the meeting was preceded by a statement from Amanda Norton, FDA Office of the Ombudsman, indicating that three citizens petitions had been filed with the Agency requesting that the meeting be postponed until the jurisdictional issue associated with contrast agents is resolved. She stated that the petitions were denied but that FDA was addressing the issues raised concerning jurisdiction of these agents.
Five speakers requested time to speak during the Open Public portion of the meeting. They included Peter Safir from Kleinfeld, Kaplan, and Becker speaking on behalf of Bracco Diagnostics; Steven Quay, M.D., Ph.D., President of Sonus Pharmaceuticals; Alan Carpenter, Vice President of Clinical Research, Regulatory Affairs and Discovery Research, Dupont Merck; and G. Scott Gazelle, M.D. Brigham and Womens and Massachusetts General Hospitals who was supported by Bracco Diagnostics. They all spoke about the jurisdictional issues associated with contrast media. The thrust of these presentations and the petitions submitted to FDA were that these devices should be regulated as drugs or at the very least subjected to the same requirements that CDER requires for other contrast agents. Kenneth Widder, M.D. CEO and Chairman of the Board of Molecular Biosystems then provided a historical perspective regarding classification of their products (Albunex and FS069) as devices and said that they had worked with the agency in conducting their investigations and preparing their submission.
Kimber Richter, M.D. concluded this portion of the meeting by instructing the panel members to focus their attention on the science supporting the applications before them.
The remainder of the morning was devoted to a discussion of a supplement to the Albunex PMA. This application was for a new indication for use of this ultrasound contrast agent in the assessment of fallopian tube patency. The recommendation of the Panel was approval with conditions. The conditions imposed were to revise the gynecology precaution section of the labeling to state that "Patients with current gynecological infection should be treated with antibiotics and the procedure delayed until resolution of the infection." The second condition the Panel requested was that this precaution section also contain a section which indicates that the procedure should only be carried out by practitioners with adequate training in ultrasonography and a thorough knowledge of the procedure.
P960045
The afternoon session was spent discussing an original PMA submitted by Molecular Biosystems, Inc. (MBI) for an ultrasound contrast agent, FS069, for use in echocardiography. This agent is a second generation, albumin based compound in which the air filled microspheres have the air replaced by perfluoropropane which extends the duration of the microspheres in the body and thus the available imaging time. After a thorough discussion of the issues associated with the product the Panel voted for approval. The CDER consultant to the panel indicated that he concurred with this vote and that the information provided by the sponsor was adequate to justify approval of FS069 for its intended use in echocardiography. No additional conditions were recommended by the Panel.
(Contact: John Monahan, 301-524-1212)
[A transcript of this meeting may be purchased from CASET Associates, Ltd., 10201 Lee Highway, Suite 160, Fairfax, VA 22030, telephone 703-352-0091, fax 703-591-2804, or from FDA, Freedom of Information Staff (HFI-35), 5600 Fishers Lane, Rockville, MD 20857, telephone 301-443-6310, fax 301-443-1726.]
Summary is not available. Complete transcript is available at http://www.fda.gov/ohrms/dockets/ac/97/transcpt/3319t1.pdf.
Summary is not available. Complete transcript is available at http://www.fda.gov/ohrms/dockets/ac/97/transcpt/3353t1.pdf.
Summary is not available. Complete transcript is available at http://www.fda.gov/ohrms/dockets/ac/98/transcpt/3418t1.pdf.
Summary is not available. Complete transcript is available:
8/17/98 to 8/17/98
8/17/98 to 8/18/98
Radiological Devices Panel - May 17, 1999
The Radiological Devices Panel met on May 17, 1999, to discuss and make recommendations on bone strength assessment, with a focus on the use of gender and race specific databases in assessing fracture risk, and their applicability to bone densitometry and sonometry device labeling and output.
The meeting was opened with briefings on the Y2K issue’s impact on medical devices and postmarket surveillance information and its role in CDRH.
Seven speakers from the medical and academic communities made presentations including the basis for the currently used bone assessment paradigms and the strengths and weaknesses of the various measurement parameters. Four speakers from industry described various methods for reporting the results of bone strength assessments.
The presentations were followed by a discussion period after which the members of the panel made the following key recommendations:
And comments:
Robert J. Doyle
Executive Secretary
Transcripts may be purchased from Miller Reporting Company, 507 C Street, N.E., Washington, DC 20002, 1-800-833-7947 or (202) 546-6666; or from the Food and Drug Administration, Freedom of Information Staff (FOI), 5600 Fishers Lane, HFI-35, Rockville, MD 20852, 301-827-6500.
Radiological Devices Panel - December 16, 1999
The Radiological Devices Panel met on December 16, 1999 to discuss an original PMA application, P990066 from General Electric Medical Systems for their Senographe 2000D a full-field digital mammography device. The device is intended to generate mammographic images for use in the screening for and diagnosis of breast cancer.
Following discussion of the issues associated with this PMA the Panel unanimously recommended approval of the PMA with conditions. The three conditions voted by the panel were: 1) that the manufacturer deploy soft-copy workstations to serve as an adjunct to hard-copy, 2) that the labeling have an executive summary that emphasizes the difference between the study population and a true screening and/or diagnostic population, and 3) that the approval of the soft-copy modality be expedited.
During the discussion it was also clear that the panel members believe that requiring a post-market study is a waste of time and valuable resources.
Contact:
Robert J. Doyle, Executive Secretary
(301) 594-1212
Transcripts may be purchased from:
(Written Request Only)
Miller Reporting Company
507 C. Street, N.E.
Washington, D.C. 20002
(202) 546-6666
-or-
Food and Drug Administration
Freedom of Information Staff (FOI)
5600 Fishers Lane, HFI-35
Rockville, MD 20852
(301) 827-6500 (voice)
(301) 443-1726 (fax)
Back to Overview
Upcoming Advisory Committee (or Panel) Meetings
(Updated December 20, 1999)
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