[Federal Register Volume 63, Number 117 (Thursday, June 18, 1998)]
[Notices]
[Pages 33375-33376]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-16141]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 98D-0388]
Draft Guidance for Industry on Topical Dermatological Drug
Product NDA's and ANDA's--In Vivo Bioavailability, Bioequivalence, In
Vitro Release and Associated Studies; 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availability of a draft guidance for industry entitled ``Topical
Dermatological Drug Product NDA's and ANDA's--In Vivo Bioavailability,
Bioequivalence, In Vitro Release and Associated Studies.'' The draft
guidance is intended to provide recommendations to sponsors of new drug
applications (NDA's), abbreviated new drug applications (ANDA's), and
supplements who intend to perform bioavailability and bioequivalence
studies for topically applied dermatological drug products during
either the preapproval or postapproval period. The agency is seeking
comments on the draft guidance.
DATES: Written comments may be submitted on the draft guidance by
August 17, 1998. General comments on the agency guidances are welcome
at any time.
ADDRESSES: Copies of this draft guidance are available on the Internet
at ``http://www.fda.gov/cder/guidance/index.htm'' .
Submit written comments on this draft guidance to the Dockets
Management Branch (HFD-305), Food and Drug Administration, 12420
Parklawn Dr., rm 1-23, Rockville, MD. 20857. 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.
FOR FURTHER INFORMATION CONTACT: Vinod P. Shah, Center for Drug
Evaluation and Research (HFD-350), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-594-5635.
SUPPLEMENTARY INFORMATION: FDA is announcing the availability of a
draft guidance for industry entitled ``Topical Dermatological Drug
Product NDA's and ANDA's--In Vivo Bioavailability, Bioequivalence, In
Vitro Release and Associated Studies.'' The draft guidance
[[Page 33376]]
is intended to provide recommendations to sponsors of NDA's, ANDA's,
and supplements who intend to perform, during either the preapproval or
postapproval period, bioavailability and bioequivalence studies for
topical dermatological drug products.
The definitions of ``bioavailability'' and ``bioequivalence,'' the
requirements for submitting such data in NDA's, ANDA's, and
supplements, and the types of in vivo studies that are acceptable to
establish bioavailability and bioequivalence are set forth in CFR part
320. These regulatory definitions and requirements reflect requirements
in the Federal Food, Drug, and Cosmetic Act and other agency
regulations.
Generally, bioavailability and bioequivalence of a drug product can
be assessed through measurement of the active moiety(ies)/active
ingredient(s) in an accessible biologic fluid such as blood, plasma,
and urine. For some drug products, including topical dermatological
drug products, it is not possible to use pharmacokinetic measurements
of the active moiety(ies)/active ingredient(s) in blood, plasma, or
urine to document bioequivalence because topical dermatological
products generally do not produce measurable concentrations in
extracutaneous biological fluids. This draft guidance document proposes
other methods to establish bioavailability and bioequivalence,
including the following types of studies: (1) Clinical studies; (2)
pharmacodynamic studies; (3) dermatopharmacokinetic studies; and (4) in
vitro studies. These approaches are discussed at 21 CFR 320.24,
although these regulations do not provide specific methodologic
approaches. In addition to general comments, FDA welcomes the
submission of data that support or refute the use of any of these
approaches, especially dermatopharmacokinetic approaches, in the
documentation of bioavailiability and bioequivalence of topical
dermatological drug products. FDA also welcomes the submission of
relevant clinical, dermatopharmacokinetic, and in vitro release data
for further evaluation of these approaches in the guidance. At some
time following receipt of public comments and other information to this
draft guidance, FDA intends to discuss the guidance and the public
response to the guidance before a joint meeting of the Advisory
Committee for Pharmaceutical Science and the Dermatologic and
Ophthalmic Drugs Advisory Committee.
This draft guidance is a level 1 draft guidance document consistent
with FDA's good guidance practices (62 FR 8961, February 27, 1997). It
represents the agency's current thinking on bioavailability and
bioequivalence approaches for topical dermatological 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.
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. Requests should be identified with the
docket number found in brackets in the heading of this document. Copies
of 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: June 8, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-16141 Filed 6-17-98; 8:45 am]
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