[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]
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