[Federal Register Volume 63, Number 32 (Wednesday, February 18, 1998)]
[Notices]
[Page 8208]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-3982]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 98D-0077]
Draft Guidance for Industry: Clinical Development Programs for
Drugs, Devices, and Biological Products Intended for the Treatment of
Osteoarthritis (OA); Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of, and requesting comment on a draft guidance for
industry entitled ``Clinical Development Programs for Drugs, Devices,
and Biological Products Intended for the Treatment of Osteoarthritis
(OA).'' The purpose of the draft guidance and the discussion questions
appended to the draft guidance is to stimulate discussion and seek
input about designing clinical programs for the development of drugs,
devices, and biological products intended for the treatment of OA. The
draft guidance and appended questions will be the topics of discussion
at the Arthritis Advisory Committee meeting to be held on February 20,
1998.
DATES: Written comments may be submitted on the draft guidance document
by April 20, 1998. General comments on the agency guidance documents
are welcome at any time.
ADDRESSES: Copies of the draft guidance and appended questions are
available on the Internet at ``http://www.fda.gov/cder/guidance/
index.htm'' or ``http://www.fda.gov/cber/guidelines.htm.'' Written
requests for single copies of the draft guidance and appended questions
should be submitted to the Drug Information Branch (HFD-210), Center
for Drug Evaluation and Research, Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857. Send one self-addressed adhesive
label to assist that office in processing your requests. Submit written
comments on the draft guidance to the Dockets Management Branch (HFD-
305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23,
Rockville, MD 20857. The February 20, 1998, meeting of the Arthritis
Advisory Committee will be held at the Holiday Inn Bethesda, 8120
Wisconsin Ave., Bethesda, MD 20814.
FOR FURTHER INFORMATION CONTACT: Chin C. Koerner, Center for Drug
Evaluation and Research (HFD-550), Food and Drug Administration, 9201
Corporate Blvd., Rockville, MD 20850, 301-827-2090.
SUPPLEMENTARY INFORMATION: Currently, treatment for OA is fundamentally
symptomatic, with no data available on the impact on long-term
outcomes. Clinical trial experience with OA has been limited to short-
term studies in patients with knee or hip OA and generalized OA
normally has not been appropriate for assessing OA agents. A number of
novel approaches are under study for the treatment of OA, as companies,
clinicians, and patients search for more effective therapeutics. The
focus of the discussion during the February 20, 1998, Arthritis
Advisory Committee Meeting will be: (1) The appropriateness of the
proposed claims for improvement of pain, function, structure, and
durability, as well as delay in new OA and delay in joint replacement;
and (2) trial designs and analyses to support those claims. Notice of
the meeting of the Arthritis Advisory Committee appeared in the Federal
Register of January 16, 1998 (63 FR 2682).
The purpose of the draft guidance and the appended questions is to
stimulate discussion and seek input regarding the design of clinical
programs for developing drugs, devices, or biological products intended
for the treatment of OA. Discussion during the meeting will enable
public participation and the exchange of ideas on developing and
assessing new treatment modalities for OA, types of claims that might
be reasonably pursued, and data necessary to support such claims. The
discussions are not intended to result in consensus among participants;
they are intended to contribute to the formulation of suggestions to
drug, device, and biological product sponsors for designing appropriate
study protocols and expediting product development.
Interested persons may submit written comments on the draft
document to the Dockets Management Branch (address above). Two copies
of any comments are to be submitted, except that individuals may submit
one copy. Comments are to be identified with the docket number found in
brackets in the heading of this document. The draft document, appended
questions, and received comments may be seen in the office above
between 9 a.m. and 4 p.m., Monday through Friday.
Dated: February 11, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-3982 Filed 2-12-98; 1:39pm]
BILLING CODE 4160-01-F
