[Federal Register Volume 64, Number 38 (Friday, February 26, 1999)]
[Notices]
[Pages 9516-9517]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-4763]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 99D-0236]
Draft Guidance for Industry on Skin Irritation and Sensitization
Testing of Generic Transdermal Drug Products; 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availability of a draft guidance for industry entitled ``Skin
Irritation and Sensitization Testing of Generic Transdermal Drug
Products.'' This draft guidance provides assistance to sponsors of
abbreviated new drug applications (ANDA's) by recommending study
designs and scoring systems that can be used to test skin irritation
and sensitization during development of transdermal products. To fully
evaluate the equivalence of a transdermal product to a reference listed
drug, skin irritation and sensitization should be assessed because skin
conditions may affect the efficacy or safety of the product. This
guidance does not address the actual bioequivalence studies that would
be needed for a particular transdermal drug product.
DATES: Written comments may be submitted on the draft guidance document
by April 27, 1999. General comments on agency guidance documents are
welcome at any time.
ADDRESSES: Copies of this draft guidance for industry are available on
the Internet at ``http://www.fda.gov/
[[Page 9517]]
cder/guidance/index.htm''. Submit written requests for single copies of
the draft guidance to the Drug Information Branch (HFD-210), Center for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comments on the draft guidance to the Dockets Management Branch (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: Mary Fanning, Center for Drug
Evaluation and Research (HFD-600), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-5845.
SUPPLEMENTARY INFORMATION: FDA is announcing the availability of a
draft guidance for industry entitled ``Skin Irritation and
Sensitization Testing of Generic Transdermal Drug Products.''
Transdermal products have properties that may lead to skin irritation
and/or sensitization. The delivery system, or the system in conjunction
with the drug substance, may cause these skin reactions. In the
development of transdermal products, dermatologic adverse events are
evaluated primarily with animal studies and safety evaluations in the
context of large clinical trials generally associated with the
submission of new drug applications. Separate skin irritation and skin
sensitization studies also are used for this purpose. These later
studies are designed to detect irritation and sensitization under
conditions of maximal stress. These studies may be used during the
assessment of transdermal drug products for ANDA's.
This draft level 1 guidance is being issued consistent with FDA's
good guidance practices (62 FR 8961, February 27, 1997). It represents
the agency's current thinking on skin irritation and sensitization
testing of generic transdermal drug products. 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 statute, regulations, or
both.
Interested persons may submit written comments on the draft
guidance to the Dockets Management Branch (address above). Two copies
of any 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 Dockets
Management Branch between 9 a.m. and 4 p.m., Monday through Friday.
Dated: February 19, 1999.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 99-4763 Filed 2-25-99; 8:45 am]
BILLING CODE 4160-01-F
