[Federal Register Volume 67, Number 212 (Friday, November 1, 2002)]
[Notices]
[Pages 66646-66647]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-27885]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02D-0427]


Guidance for Industry on Antiretroviral Drugs Using Plasma Human 
Immunodeficiency Virus Ribonucleic Acid Measurements--Clinical 
Considerations for Accelerated and Traditional Approval; 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 guidance for industry entitled ``Antiretroviral Drugs 
Using Plasma HIV RNA Measurements--Clinical Considerations for 
Accelerated and Traditional Approval.'' This guidance is intended to 
assist sponsors in the clinical development of drugs for the treatment 
of human immunodeficiency virus (HIV) infection. Specifically, this 
guidance addresses the agency's current thinking regarding designs of 
clinical trials that use HIV ribonucleic acid (RNA) measurements to 
support accelerated and traditional approvals of antiretroviral drug 
products.

DATES: Submit written or electronic comments on agency guidances at any 
time.

ADDRESSES: Submit written requests for single copies of this guidance 
to the Division of Drug Information (HFD-240), 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 guidance to the Dockets Management Branch (HFA-305), Food and 
Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. 
Submit electronic comments to http://www.fda.gov/dockets/ecomments. See 
the SUPPLEMENTARY INFORMATION section for electronic access to the 
guidance document.

FOR FURTHER INFORMATION CONTACT: Jeffrey S. Murray, Center for Drug 
Evaluation and Research (HFD-530), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-2330.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Antiretroviral Drugs Using Plasma HIV RNA Measurements--
Clinical Considerations for Accelerated and Traditional Approval.'' 
This guidance is intended to assist sponsors in the clinical 
development of drugs for the treatment of HIV infection. Specifically, 
this guidance addresses the agency's current thinking regarding designs 
of clinical trials that use HIV RNA measurements to support accelerated 
and traditional approvals of antiretroviral drug products. It is also 
intended to serve as a focus for continued discussions among the 
Division of Antiviral Drug Products (DAVDP), pharmaceutical sponsors, 
the academic community, and the public.
    The draft version of this document, first issued in August 1999, 
was based on a DAVDP advisory committee meeting, convened in July 1997, 
to discuss the use of HIV RNA endpoints for traditional approval of 
antiretroviral drugs. This document has been updated to address public 
comments to the draft version and to include pertinent information from 
a DAVDP advisory committee meeting held in January 2001 that addressed 
issues relating to trial design in HIV-infected patients who have 
already been heavily treated for the disease. The guidance summarizes 
the rationale for using HIV RNA as a primary endpoint in clinical 
trials to support both accelerated and traditional approval. It 
describes the amount and type of safety and efficacy data recommended 
for new drug applications. The guidance also reviews pertinent clinical 
trial design issues including choice of control arms, study procedures, 
and statistical considerations. An appendix addresses the use of 
experimental HIV RNA assays in phase 3 studies.
    This guidance does not address specific phase-1 and -2 development 
issues, development of alternate dosing regimens, or the use of HIV-1 
resistance testing. These issues will be addressed in separate future 
guidance documents.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
agency's current thinking on clinical considerations for accelerated 
and

[[Page 66647]]

traditional approval of antiretroviral drugs using plasma HIV RNA 
measurements. 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 statutes and regulations.

II. Comments

    Interested persons may, at any time, submit written or electronic 
comments on the guidance to the Dockets Management Branch (see 
ADDRESSES). 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 
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.

III. Electronic Access

    Persons with access to the Internet may obtain the document at 
either http://www.fda.gov/cder/guidance/index.htm or http://www.fda.gov/ohrms/dockets/default.htm.

    Dated: October 28, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-27885 Filed 10-31-02; 8:45 am]
BILLING CODE 4160-01-S