[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]
-----------------------------------------------------------------------
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Draft Guidance for Industry and Review Staff on Nonclinical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.
-----------------------------------------------------------------------
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availability of a draft guidance for industry and review staff entitled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 The draft
guidance provides recommendations concerning development of safety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this draft guidance before it begins work on the final version of the
guidance, submit written or electronic comments on the draft guidance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ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information (HFD-240), Center for Drug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on the draft guidance to the Division of Dockets Management (HFA-305),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draft guidance document.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FDA is announcing the availability of a draft guidance for industry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]
BILLING CODE 4160-01-S