[Federal Register Volume 64, Number 31 (Wednesday, February 17, 1999)]
[Notices]
[Pages 7898-7899]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-3776]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 96D-0067]
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 guidance for industry entitled ``Clinical Development
Programs for Drugs, Devices, and Biological Products for the Treatment
of Rheumatoid Arthritis (RA).'' This 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
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.
DATES: General comments on agency guidance documents are welcome at any
time.
ADDRESSES: Copies of the guidance are available on the Internet at
``http://www.fda.gov/cder/guidance/index.htm'', or ``http://
www.fda.gov/cber/guidelines.htm''. Submit written requests for single
copies of the guidance for industry to the Drug Information Branch
(HFD-210), Center for Drug Evaluation and Research (CDER), Food and
Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, or Office
of Communication, Training and Manufacturers Assistance (HFM-40),
Center for Biologics Evaluation and Research (CBER), Food and Drug
Administration, 1401 Rockville Pike, Rockville, MD 20852-1448. Call
888-CBERFAX or 301-827-3844 for copies by fax or CBER's Voice
Information System at 800-835-4709 or 301-827-1800 for copies by mail.
Send one self-addressed adhesive label to assist the offices in
processing your requests. Submit written comments on the guidance to
the Dockets Management Branch (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
[[Page 7899]]
Kent R. Johnson, Center for Drug Evaluation and Research (HFD-550),
Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857,
301-827-2080; or
Jeffrey N. Siegel, Center for Biologics Evaluation and Research
(HFM-582), Food and Drug Administration, 1401 Rockville Pike,
Rockville, MD 20852, 301-827-5094; or
Sahar M. Dawisha, Center for Devices and Radiological Health (HFZ-
410), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD
20850, 301-594-3091, ext. 196, FAX 301-594-2358.
SUPPLEMENTARY INFORMATION: FDA is announcing the availability of a
guidance for industry entitled ``Clinical Development Programs for
Drugs, Devices, and Biological Products for the Treatment of Rheumatoid
Arthritis (RA).'' The guidance contains recommendations on the timing,
design, and conduct of preclinical and clinical trials for RA products
and on special considerations for juvenile RA.
This guidance has been under development since 1995. The first
version of the 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, on March 27, 1996, and on July 23, 1996. On February 5,
1997, the draft guidance was discussed at a meeting of the Arthritis
Advisory Committee. Another draft version, published for comment on
March 18, 1998 (63 FR 13259), incorporated suggestions made during the
February 5, 1997, Arthritis Advisory Committee. In developing this
final version of the guidance, FDA considered comments submitted to the
docket on the March 18, 1998, draft guidance.
This guidance represents the agency's current thinking on RA. 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.
Interested persons may, at any time, submit to the Dockets
Management Branch (address above) written comments on the guidance. 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
guidance and received comments may be seen in the office above between
9 a.m. and 4 p.m., Monday through Friday.
Dated: February 10, 1999.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 99-3776 Filed 2-16-99; 8:45 am]
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