[Federal Register: May 17, 2002 (Volume 67, Number 96)]
[&thnsp;Notices]               
[Page 35122-35123]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr17my02-77]                         

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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Draft Guidance for Industry on Topical Dermatological Drug 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withdrawal of a draft guidance for industry entitled “Topical 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withdraw the draft guidance.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of a draft guidance for industry entitled “Topical Dermatological 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draft guidance was intended to provide recommendations to sponsors of 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comments on the draft guidance were to be submitted by August 17, 1998.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 The draft guidance and public comments were 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]
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