[Federal Register Volume 73, Number 46 (Friday, March 7, 2008)]
[Notices]
[Page 12454]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-4481]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-D-0142]


Draft Guidance for Industry and Review Staff on Nonclinical 
Safety Evaluation of Reformulated Drug Products and Products Intended 
for Administration by an Alternate Route; 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availability of a draft guidance for industry and review staff entitled 
``Nonclinical Safety Evaluation of Reformulated Drug Products and 
Products Intended for Administration by an Alternate Route.'' The draft 
guidance provides recommendations concerning development of safety 
profiles to support approval of reformulated drug products and products 
proposed for use by a route of administration for which the product was 
not previously approved.

DATES:  Although you can comment on any guidance at any time (see 21 
CFR 10.115(g)(5)), to ensure that the agency considers your comment on 
this draft guidance before it begins work on the final version of the 
guidance, submit written or electronic comments on the draft guidance 
by May 6, 2008.

ADDRESSES:  Submit written requests for single copies of the draft 
guidance to the Division of Drug Information (HFD-240), Center for Drug 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on the draft guidance to the Division of Dockets Management (HFA-305), 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://www.regulations.gov. See 
the SUPPLEMENTARY INFORMATION section for electronic access to the 
draft guidance document.

FOR FURTHER INFORMATION CONTACT:  Paul Brown, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, rm. 5172, Silver Spring, MD 20993-0002, 301-
796-0856.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
and review staff entitled ``Nonclinical Safety Evaluation of 
Reformulated Drug Products and Products Intended for Administration by 
an Alternate Route.'' This draft guidance is intended for individuals 
or organizations and review staff in the Center for Drug Evaluation and 
Research involved in the development and review of new formulations of 
products containing previously approved drug substances and proposals 
for existing formulations to be used in a new route of administration. 
This draft guidance assumes that the drug substance has already been 
used in an approved drug product. It outlines the nonclinical 
information generally recommended to support the development of a new 
formulation containing a previously approved drug substance.
    This draft guidance also provides nonclinical evaluation 
information for formulations intended for use by new routes of 
administration even if there is no change in the composition of the 
formulation. Although this situation does not represent a 
reformulation, it is appropriate in this case to reevaluate the 
toxicity information using considerations outlined in the draft 
guidance.
    This draft guidance does not absolve the sponsor from providing 
complete nonclinical information for a drug product, either directly or 
through a right of reference to such information or by relying on the 
finding of safety and effectiveness for a listed drug and establishing 
a clinical bridge to that listed drug. This draft guidance pertains to 
new formulations containing previously approved drug substances only 
and does not address the safety evaluation of excipients.
    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 safety 
evaluation of reformulated drug products, including products intended 
for administration by an alternate route. 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. Received comments may be seen in the 
Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.
    Please note that on January 15, 2008, the FDA Web site transitioned 
to the Federal Dockets Management System (FDMS). FDMS is a Government-
wide, electronic docket management system. Electronic submissions will 
be accepted by FDA through FDMS only.

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: February 29, 2008.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E8-4481 Filed 3-6-08; 8:45 am]
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