[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Draft Guidance for Industry on Topical Dermatological Drug 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availability of a draft guidance for industry entitled ``Topical 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 The draft 
guidance is intended to provide recommendations to sponsors of new drug 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comments on the draft guidance.

DATES: Written comments may be submitted on the draft guidance by 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ADDRESSES: Copies of this draft guidance are available on the Internet 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    Submit written comments on this draft guidance to the Dockets 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draft guidance for industry entitled ``Topical Dermatological Drug 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 The draft guidance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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