[Federal Register Volume 64, Number 135 (Thursday, July 15, 1999)]
[Notices]
[Pages 38201-38202]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-18031]
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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Draft Guidance for Industry: Clinical Development Programs for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; request for comments.
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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availability of a draft guidance for industry entitled ``Clinical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
Intended for the Treatment of Osteoarthritis (OA).'' The draft guidance
is intended to stimulate discussion about designing clinical programs
for the development of drugs, devices, and biological products intended
for the treatment of osteoarthritis (OA). This draft guidance reflects
comments received in response to a previous draft version of the
guidance available in February 1998.
DATES: Written comments on the draft guidance document may be submitted
by September 13, 1999. General comments on 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ADDRESSES: Copies of the draft guidance and appended questions are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''. Submit
written requests for single copies of the draft guidance and appended
questions to the Drug Information Branch (HFD-210), Center for Drug
Evaluation and Research, Food and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, or to the Office of Communication, Training
and Manufacturers Assistance (HFM-40), Center for Biologics Evaluation
and Research, Food and Drug Administration, 1401 Rockville Pike,
Rockville, MD 20852-1448; FAX: 1-888-CBERFAX or 301-827-3844, mail: the
Voice Information System at 800-835-4709 or 301-827-1800. 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 Submit written comments on the draft guidance to the Dockets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, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Sandra N. Cook, Center for Drug
Evaluation and Research (HFD-550), 9201 Corporate Blvd., Rockville, MD
20850, 301-827-2090.
SUPPLEMENTARY INFORMATION: Currently, treatment for OA is fundamentally
symptomatic, with no data available 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
[[Page 38202]]
effective treatments. The design of clinical programs for developing
drugs, devices, or biological products intended for the treatment of OA
was the subject of a previous draft guidance issued in February 1998
(63 FR 8208, February 18, 1998). The February 1998 draft guidance
generated several comments and was the subject of discussion at the
Arthritis Advisory Committee meeting held on February 20, 1998.
The agency found the comments and the discussion at the advisory
committee meeting very helpful in developing the recommendations to
industry, contained in the guidance, on the design of clinical programs
for developing drugs, devices, or biological products intended for the
treatment of OA. However, the agency believes that more public input
would be beneficial in preparing a final version of the guidance.
Accordingly, the agency has decided to issue this revised version of
the guidance as a draft.
This level 1 draft guidance is being issued consistent with FDA's
good guidance practices (62 FR 8961, February 27, 1997). The draft
guidance represents the agency's current thinking on developing drugs,
devices, or biological products intended for the treatment of OA. 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, on or before September 13, 1999, submit to
the Dockets Management Branch (address above) written comments on the
draft document. 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: July 8, 1999.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy Coordination.
[FR Doc. 99-18031 Filed 7-14-99; 8:45 am]
BILLING CODE 4160-01-F
