[Federal Register: June 28, 2005 (Volume 70, Number 123)]
[Notices]
[Page 37102-37103]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28jn05-71]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005D-0240]
Draft Guidance for Industry on Gingivitis: Development and
Evaluation of Drugs for Treatment or Prevention; 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availability of a draft guidance for industry entitled ``Gingivitis:
Development and Evaluation of Drugs for Treatment or Prevention.'' The
draft guidance is intended to assist sponsors in developing clinical
trials for drug products that treat or prevent gingivitis. It addresses
specific protocol design elements as well as general concerns about
drugs for this indication.
DATES: Submit written or electronic comments on the draft guidance by
August 29, 2005. General comments on agency guidance documents are
welcome at any time.
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information (HFD-240), Center for Drug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on the draft guidance to the Division of Dockets Management (HFA-305),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access to the draft guidance document.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: Frederick Hyman, Center for Drug
Evaluation and Research (HFD-540), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-2020.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled
[[Page 37103]]
``Gingivitis: Development and Evaluation of Drugs for Treatment or
Prevention.'' This guidance is intended to assist sponsors in
developing clinical trials for drug products that treat or prevent
gingivitis.
Gingivitis, an inflammation of the soft tissues that surround the
teeth, is a part of the wider classification of periodontal diseases,
which include gingivitis at the milder end and periodontitis at the
more severe end. In 1986, FDA approved Peridex (0.12% chlorhexidine
gluconate rinse), the first prescription product for gingivitis. In
1997, Colgate's Total toothpaste (0.30% triclosan, 0.24% sodium
fluoride) was approved through the new drug application (NDA) process
as an over-the-counter (OTC) dentifrice that also has a gingivitis
indication. During the past several decades, many products have also
entered the marketplace as OTC products that were purported to treat or
prevent gingivitis. As a result of the proliferation and promotion of
those products, the agency convened a subcommittee of the Dental
Products Panel (the Subcommittee) in 1993 to evaluate OTC products that
make gingivitis and related claims and that were in the marketplace
without an NDA. The Subcommittee's charge was to review the submitted
data and to report its findings on the safety and effectiveness of OTC
ingredients for the reduction or prevention of gingivitis. On May 29,
2003, a final subcommittee report was published in the Federal Register
(68 FR 32232) as an advance notice of proposed rulemaking, the first
step in establishing an OTC monograph for these drug products.
Unlike the NDA process that consists of a review of the entire drug
product, the monograph process reviews only active ingredients in the
class of drug products for safety and efficacy. Until the monograph is
finalized, only gingivitis products containing active ingredients that
were marketed in the United States before 1975 can continue to be
marketed. Any manufacturer attempting to enter the marketplace with a
gingivitis product containing an active ingredient that has no prior
marketing history in the United States should either petition the
developing monograph to consider its inclusion or submit a new NDA for
approval before marketing. Sponsors of OTC antigingivitis drugs with
active ingredients that the Subcommittee classified as needing further
information to make a decision are encouraged to submit further data
for review. As a result of these actions, FDA is publishing this
guidance document on the development of antigingivitis drugs. The
guidance is intended to aid drug sponsors in developing clinical trials
either for submitting additional information to the antigingivitis
rulemaking, or for gaining approval for a new antigingivitis drug
through the NDA process.
This guidance document provides assistance in several ways. It
addresses specific design elements such as choosing inclusionary and
exclusionary criteria, selecting relevant endpoints, assessing
gingivitis, determining the clinical significance of the effect, and
collecting meaningful safety data. It also provides comments on general
concerns (e.g., prevention versus treatment claims, OTC versus
prescription status, special population enrollment, and nonclinical
development issues related to products that are intended for
administration within the oral cavity for the treatment or prevention
of gingivitis).
This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the agency's current thinking on the
development and evaluation of drugs for treatment or prevention of
gingivitis. 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 statutes and regulations.
II. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one paper copy.
Comments 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 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: June 22, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-12764 Filed 6-27-05; 8:45 am]
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