[Federal Register Volume 63, Number 52 (Wednesday, March 18, 1998)]
[Notices]
[Pages 13259-13260]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-6908]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 96D-0067]


Draft Guidance for Industry on Clinical Development Programs for 
Drugs, Devices, and Biological Products for the Treatment of Rheumatoid 
Arthritis (RA); 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availability of a draft guidance for industry entitled ``Clinical 
Development Programs for Drugs, Devices, and Biological Products for 
the Treatment of Rheumatoid Arthritis (RA).'' This draft guidance is 
intended to assist developers of drugs, biological products, or medical 
devices intended for the treatment of rheumatoid arthritis (RA). It 
provides guidance on the types of claims that could be considered for 
such products and on clinical evaluation programs that could support 
those claims. The draft guidance also contains recommendations on the 
timing, design, and conduct of preclinical and clinical trials for RA 
products and on special considerations for juvenile RA. The agency is 
seeking comments on the draft guidance.

DATES: Written comments may be submitted on the draft guidance document 
by April 17, 1998. General comments on the agency guidance documents 
are welcome at any time.

ADDRESSES: Copies of this draft guidance are available on the Internet 
at http://www.fda.gov/cder/guidance/index.htm and at http://
www.fda.gov/cber/guidelines.htm.
    Submit written comments on the draft guidance to the Dockets 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.
FOR FURTHER INFORMATION CONTACT: Rose E. Cunningham, Center for Drug 
Evaluation and Research (HFD-006), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-594-5468.

SUPPLEMENTARY INFORMATION: FDA is announcing the availability of a 
draft guidance for industry entitled ``Clinical Development Programs 
for Drugs, Devices, and Biological Products for the Treatment of 
Rheumatoid Arthritis (RA).'' The draft guidance also contains 
recommendations on the timing, design, and conduct of preclinical and 
clinical

[[Page 13260]]

trials for RA products and on special considerations for juvenile RA.
    This draft guidance has been under development since 1995. The 
first version of the draft guidance was completed in March 1996. An 
additional section on juvenile RA was added in May of that year. A 
second version was completed in January 1997. Two public workshops have 
been held on the topic: One was held on March 27, 1996 (61 FR 8961, 
March 6, 1996), and the other was held on July 23, 1996 (61 FR 32447, 
June 24, 1996). On February 5, 1997 (62 FR 4535, January 30, 1997), the 
draft guidance was discussed at a meeting of the Arthritis Advisory 
Committee. This draft guidance is the result of those efforts.
    The draft guidance represents the agency's current thinking on 
rheumatoid arthritis. It does not create or confer any rights for or on 
any person and does not operate to bind FDA or the public. An 
alternative approach may be used if such approach satisfies the 
requirements of the applicable statute, regulations, or both.
    Written requests for single copies of the draft guidance for 
industry 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. 
Interested persons may submit written comments on the draft guidance to 
the Dockets Management Branch (address above). Two copies of any 
comments are to be submitted, except that individuals may submit one 
copy. Comments and requests are to be identified with the docket number 
found in brackets in the heading of this document. The draft guidance 
and received comments may be seen in the office above between 9 a.m. 
and 4 p.m., Monday through Friday.

    Dated: March 8, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-6908 Filed 3-17-98; 8:45 am]
BILLING CODE 4160-01-F