ACTION ALERT: USFDA FAST-TRACKS APPROVAL PROCESS FOR FORESKIN-DERIVED PRODUCTS (fwd)
ACTION ALERT: USFDA FAST-TRACKS APPROVAL PROCESS FOR FORESKIN-DERIVED PRODUCTS
Public Comment Period Cut Short.
Closed Presentation Planned.
Written Comments Must Be Received by Thursday, 1/22/98.
On January 29, 1998, the committee will discuss, make recommendations, and
vote on premarket approval applications (PMA) for a wound dressings for use
on diabetic foot ulcers and venous stasis ulcers.
The wound dressings in question are Advanced Tissued Sciences' Dermagraft
which is made from babies' foreskins.
Although this meeting was tentatively scheduled back in December, comments
would not be accepted until notification appeared in the Federal Register
and it was assigned a Docket number. They've left barely enough time to get
a first class letter to Washington during the comment period. So use e-mail
or fax.
Comments from legal and medical professionals will carry extra weight but
anyone can submit comments. It's appropriate to raise the human rights
issues involved with using tissue taken from unconsenting minors for the
benefit and profit of others.
Refer to "FR Doc. 98-887" in correspondence.
Comments should be directed to:
Gail Gantt
Executive Secretary
Center for Devices and Radiological Health (HFZ-410)
cooking.net">food and Drug Administration;
9200 Corporate Blvd.
Rockville, MD 20850
Telephone: 301-594-3090
>> Fax: 301-594-2358
For the FDA's guidelines for submitting comments see
"How to Comment on Proposals and Submit Petitions" at
http://www.***.com/
Federal Register Notification:
http://www.***.com/
14ja98-80
Full Text:
[Federal Register: January 14, 1998 (Volume 63, Number 9)]
[Notices]
[Page 2249]
Quote:
>From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr14ja98-80]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
General and Plastic Surgery Devices Panel of the Medical Devices
Advisory Committee; Notice of Meeting
AGENCY: cooking.net">food and Drug Administration, HHS.
ACTION: Notice.
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This notice announces a forthcoming meeting of a public advisory
committee of the cooking.net">food and Drug Administration (FDA). At least one
portion of the meeting may be closed to the public.
Name of Committee: General and Plastic Surgery Devices Panel of the
Medical Devices Advisory Committee.
General Function of the Committee: To provide advice and
recommendations to the agency on FDA regulatory issues.
Date and Time: The meeting will be held on January 29, 1998, 8:45
a.m. to 6 p.m., and January 30, 1998, 8:45 a.m. to 1:30 p.m.
Location: Gaithersburg Marriott Washingtonian Center, 9751
Washingtonian Blvd., Salons F and G, Gaithersburg, MD.
Contact Person: Gail G. Gantt, Center for Devices and Radiological
Health (HFZ-410), cooking.net">food and Drug Administration, 9200 Corporate Blvd.,
Rockville, MD 20850, 301-594-3090, or FDA Advisory Committee
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC
area), code 12519. Please call the Information Line or access the
Internet address of http://www.***.com/ for up-to-date information
on this meeting.
Agenda: On January 29, 1998, the committee will discuss, make
recommendations, and vote on one premarket approval application (PMA)
for a wound dressing for use on diabetic foot ulcers and a second PMA
for a wound dressing for use on venous stasis ulcers. On January 30,
1998, the committee will discuss, make recommendations, and vote on a
PMA for a skin adhesive for wound edge approximation.
Procedure: On January 29, 1998 from 8:45 a.m. to 10 a.m and from 11
a.m. to 6 p.m., and on January 30, 1998, from 8:45 a.m. to 1:30 p.m.,
the meeting is open to the public. Interested persons may present data,
information, or views, orally or in writing, on issues pending before
the committee. Written submissions may be made to the contact person by
January 22, 1998. {*filter*}presentations from the public will be scheduled
between approximately 8:45 a.m. and 9:45 a.m. on January 29 and 30,
1998. Time allotted for each presentation may be limited. Those
desiring to make formal {*filter*}presentations should notify the contact
person before January 22, 1998, and submit a brief statement of the
general nature of the evidence or arguments they wish to present, the
names and addresses of proposed participants, and an indication of the
approximate time requested to make their presentation.
Closed Presentation of Data: On January 29, 1998, from 10 a.m to 11
a.m. the meeting may be closed to permit discussion and review of trade
secret and/or confidential information presented by the PMA sponsor(s)
(5 U.S.C. 552b(c )(4)).
FDA regrets that it was unable to publish this notice 15 days prior
to the January 29 and 30, 1998, General and Plastic Surgery Devices
Panel of the Medical Devices Advisory Committee meeting. Because the
agency believes there is some urgency to bring this issue to public
discussion and qualified members of the General and Plastic Surgery
Devices Panel of the Medical Devices Advisory Committee were available
at this time, the Commissioner concluded that it was in the public
interest to hold this meeting even if there was not sufficient time for
the customary 15-day public notice.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C., app. 2).
Dated: January 8, 1998.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 98-887 Filed 1-9-98; 1:52 pm]
BILLING CODE 4160-01-F
