[Federal Register: February 11, 2004 (Volume 69, Number 28)]
[Notices]
[Page 6673-6674]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr11fe04-81]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004D-0035]
Draft Guidance for Industry on the Preclinical and Clinical
Evaluation of Agents Used in the Prevention or Treatment of
Postmenopausal Osteoporosis; Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; request for comments.
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SUMMARY: The Food and Drug Administration (FDA) is requesting comments
on a draft guidance entitled ``Preclinical and Clinical Evaluation of
Agents Used in the Prevention or Treatment of Postmenopausal
Osteoporosis.'' The guidance was issued in 1994 (1994 draft guidance).
During the past decade, a significant body of data related to the
diagnosis, prevention, and treatment of osteoporosis has been
published. Much of this information is relevant to osteoporosis drug
development and, in particular, relates to issues surrounding clinical
trial design and duration. The agency is preparing to develop an
updated draft guidance on the same topic and is seeking comment on the
1994 draft guidance.
DATES: Submit written or electronic comments on the 1994 draft guidance
by April 12, 2004. General comments on agency guidance documents are
welcome at any time.
ADDRESSES: Submit written requests for single copies of the 1994 draft
guidance to the Division of Drug Information (HFD-240), Center for Drug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on the 1994 draft guidance to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. Submit electronic comments to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments.
See the SUPPLEMENTARY INFORMATION section for
electronic access to the draft guidance document
FOR FURTHER INFORMATION CONTACT: Randy Hedin, Center for Drug
Evaluation and Research (HFD-510), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-6392.
SUPPLEMENTARY INFORMATION:
[[Page 6674]]
I. Background
FDA, with input from an ad hoc workshop and an advisory committee,
first issued guidance on osteoporosis drug development in 1979. The
guidance was issued in response to the need for effective and safe
drugs to prevent and treat osteoporosis. The agency revised the
guidance in 1984. Most recently, FDA issued the 1994 draft guidance
entitled ``Guidelines for Preclinical and Clinical Evaluation of Agents
Used in the Prevention or Treatment of Postmenopausal Osteoporosis.''
The 1994 draft guidance recommends study designs, patient
populations for study, and techniques for evaluating skeletal mass and
fracture frequency that are considered central to demonstrating the
efficacy and safety of drugs used to treat and prevent osteoporosis.
Since issuance of the 1994 guidance, a number of drugs have been
approved for the prevention and treatment of osteoporosis. In general,
approval of these drugs was based on favorable bone mineral density and
decreased fracture incidence from 2- and 3-year placebo-controlled
trials.
Results from these trials and other published data have raised a
number of issues and questions that the agency plans to address in an
updated draft osteoporosis guidance. To aid in the development of the
draft guidance, FDA is requesting comment on the 1994 draft guidance.
The agency seeks specific comment on the following questions:
Is it appropriate to continue to use placebo
controls in fracture end-point trials?
Do fracture end-point trials need to be 3 years
in duration, or could shorter studies provide adequate evidence of a
new osteoporosis drug's effectiveness and safety?
The 1994 draft guidance was issued before the 1997 publication of
FDA's good guidance practices (GGPs) regulation (21 CFR 10.115). In
accordance with the GGPs, the agency will take into account any
comments received on the 1994 draft guidance, develop a new draft
guidance, and make it available for comment. When finalized, that
guidance will represent the agency's current thinking on the
preclinical and clinical evaluation of agents used in the prevention or
treatment of postmenopausal osteoporosis. Agency guidance 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 statutes and
regulations.
II. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments on the 1994 draft
guidance. Two copies of mailed 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 1994 draft guidance and received comments are available
for public examination in the Division of Dockets Management between 9
a.m. and 4 p.m., Monday through Friday.
III. Electronic Access
Persons with access to the Internet may obtain the document at
either http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cder/guidance/index.htm or http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www
.fda.gov/ohrms/dockets/default.htm.
Dated: January 30, 2004.
William K. Hubbard,
Associate Commissioner for Policy and Planning.
[FR Doc. 04-2999 Filed 2-10-04; 8:45 am]
BILLING CODE 4160-01-S