[Federal Register Volume 67, Number 96 (Friday, May 17, 2002)]
[Notices]
[Pages 35122-35123]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-12326]


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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Draft Guidance for Industry on Topical Dermatological Drug 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 NDAs and ANDAs--In Vivo Bioavailability, Bioequivalence, In 
Vitro Release and Associated Studies; Withdrawal

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
withdrawal of a draft guidance for industry entitled ``Topical 
Dermatological Drug Product NDAs and ANDAs--In Vivo Bioavailability, 
Bioequivalence, In Vitro Release, and

[[Page 35123]]

Associated Studies.'' After careful consideration of the comments from 
the public and public advisory committees, FDA has decided to withdraw 
the draft guidance.

FOR FURTHER INFORMATION CONTACT: Dale P. Conner, Center for Drug 
Evaluation and Research (HFD-650), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-5847.

SUPPLEMENTARY INFORMATION: In a notice published in the Federal 
Register of June 18, 1998 (63 FR 33375), FDA announced the availability 
of a draft guidance for industry entitled ``Topical Dermatological Drug 
Product NDAs and ANDAs--In Vivo Bioavailability, Bioequivalence, In 
Vitro Release and Associated Studies.'' The draft guidance was intended 
to provide recommendations to sponsors of new drug applications (NDAs), 
abbreviated new drug applications (ANDAs), and supplements on 
performing bioavailability and bioequivalence studies for topically 
applied dermatological drug products during either the preappoval or 
postapproval period. Written comments on the draft guidance were to be 
submitted by August 17, 1998. In the June 1998 notice, the agency also 
announced that it intended to discuss the guidance and the public 
response to the guidance before FDA public advisory committees. The 
draft guidance and public comments were discussed at joint meetings of 
the Advisory Committee for Pharmaceutical Science and the Dermatologic 
and Ophthalmic Drugs Advisory Committee on October 23, 1998, and 
November 17, 2000, and at a meeting of the Advisory Committee for 
Pharmaceutical Science on November 29, 2001.
    The information and comments provided to FDA raised scientific 
concerns regarding the primary method, dermatopharmacokinetics (DPK), 
recommended in the draft guidance for documenting bioavailability and/
or bioequivalence of topical dermatological drug products. The DPK 
method involves sampling of stratum corneum concentrations of drug over 
time after administration of a topical dermatological drug product. The 
information and comments from the public and advisory committees raised 
substantial doubt regarding: (1) The adequacy of the DPK method to 
assess the bioequivalence of topical dermatological drug products 
because the products are used to treat a variety of diseases in 
different parts of the skin, not just the stratum corneum and (2) the 
reproducibility of the DPK method between laboratories.
    The agency plans to explore the development of new methods and 
improvements in current methods for documenting the bioequivalence of 
topical dermatological drug products.

    Dated: May 6, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-12326 Filed 5-16-02; 8:45 am]
BILLING CODE 4160-01-S