[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Draft Guidance for Industry on Clinical Development Programs for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availability of a draft guidance for industry entitled ``Clinical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 This draft guidance is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 The draft guidance also contains recommendations on the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seeking comments on the draft guidance.
DATES: Written comments may be submitted on the draft guidance document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ADDRESSES: Copies of this draft guidance are available on the Internet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Submit written comments on the draft guidance to the Dockets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draft guidance for industry entitled ``Clinical Development Programs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 The draft guidance also contains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