[Federal Register Volume 69, Number 28 (Wednesday, February 11, 2004)]
[Notices]
[Pages 6673-6674]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-2999]


-----------------------------------------------------------------------

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Draft Guidance for Industry on the Preclinical and Clinical 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.

-----------------------------------------------------------------------

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on a draft guidance entitled ``Preclinical and Clinical Evaluation of 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 The guidance was issued in 1994 (1994 draft guidance).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updated draft guidance on the same topic and is seeking comment on the 
1994 draft guidance.

DATES: Submit written or electronic comments on the 1994 draft guidance 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ADDRESSES: Submit written requests for single copies of the 1994 draft 
guidance to the Division of Drug Information (HFD-240), Center for Drug 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on the 1994 draft guidance to the Division of Dockets Management (HFA-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://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electronic access to the draft guidance document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://www.fda.gov/cder/guidance/index.htm or 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