[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Draft Guidance for Industry: Clinical Development Programs for 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availability of, and requesting comment on a draft guidance for 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 The purpose of the draft guidance and the discussion questions 
appended to the draft guidance is to stimulate discussion and seek 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draft guidance and appended questions will be the topics of discussion 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DATES: Written comments may be submitted on the draft guidance document 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ADDRESSES: Copies of the draft guidance and appended questions are 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requests for single copies of the draft guidance and appended questions 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comments on the draft guidance to the Dockets Management Branch (HFD-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