[Federal Register: January 26, 2005 (Volume 70, Number 16)]
[Notices]
[Page 3714-3715]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26ja05-86]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005D-0004]
Draft Guidance for Industry on Nonclinical Safety Evaluation of
Drug Combinations; 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availability of a draft guidance for industry entitled ``Nonclinical
Safety Evaluation of Drug Combinations.'' The guidance provides
recommendations on nonclinical approaches to support the clinical study
and approval of fixed-dose combination products (FDCs), copackaged
products, and adjunctive therapies.
DATES: Submit written or electronic comments on the draft guidance by
April 26, 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ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information (HFD-240), Center for Drug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on the draft guidance to the Division of Dockets Management (HFA-305),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access to the draft guidance document.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: Abby Jacobs, 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FDA is announcing the availability of a draft guidance for industry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 ``Nonclinical Safety Evaluation of Drug Combinations.'' Drug
combinations include FDCs, copackaged products, and adjunctive
therapies. An FDC is a product in which two or more separate drug
components (active pharmaceutical ingredients) are combined in a single
dosage form. A copackaged product consists of two or more separate drug
products in their final dosage form, packaged together with appropriate
labeling to support the combination use. An adjunctive therapy refers
to the situation in which a patient is maintained on a second drug
product that is used together with (i.e., in adjunct to) the primary
treatment, although the relative doses are not fixed and the drugs need
not be given at the same time. Adjunctive therapy products may or may
not be labeled for concomitant use. The guidance discusses all three
types of drug combinations. However, it is only intended to describe
general guiding principles. To receive more detailed
[[Page 3715]]
advice regarding a particular drug combination development program, a
sponsor should contact the appropriate review division before
submitting an Investigational New Drug application. In addition, FDA is
in the process of publishing more specific guidance for certain
categories of drug combinations.
The guidance discusses drug combinations involving the following
items: (1) Previously marketed drugs, (2) one or more new molecular
entities (NMEs) and one or more previously marketed drugs, and (3) more
than one NME. The nonclinical studies considered important for each
type of combination may differ, depending upon the information
available on each drug component (active pharmaceutical ingredient).
The nonclinical studies that would be appropriate to adequately
characterize the combination depend on the toxicologic and
pharmacokinetic profiles of the individual drugs, the treatment
indication or indications, and the intended population.
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 nonclinical
safety evaluation of drug combinations. 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 on the 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
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 18, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-1394 Filed 1-25-05; 8:45 am]
BILLING CODE 4160-01-S