[Federal Register Volume 64, Number 169 (Wednesday, September 1, 1999)]
[Notices]
[Pages 47844-47845]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-22720]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 99D-2445]
Draft Guidance for Industry on Clinical Considerations for
Accelerated and Traditional Approval of Antiretroviral Drugs Using
Plasma HIV RNA Measurements; 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availability of a draft guidance for industry entitled ``Clinical
Considerations for Accelerated and Traditional Approval of
Antiretroviral Drugs Using Plasma HIV RNA Measurements.'' The draft
guidance is intended to assist pharmaceutical sponsors in the
development of antiretroviral drugs and to serve as a focus for
continued discussion among the agency, the public, industry, and
scientific communities regarding the use of plasma human
immunodeficiency virus (HIV) ribonucleic acid (RNA) measurements in
phase 3 clinical studies of antiretroviral drugs.
DATES: Written comments on the draft guidance may be submitted by
November 30, 1999. General comments on agency guidance documents are
welcome at any time.
ADDRESSES: Copies of the draft guidance for industry are available on
the Internet at ``http://www.fda.gov/cder/guidance/index.htm''. Submit
written requests for single copies of the draft guidance entitled
``Clinical Considerations for Accelerated and Traditional Approval of
Antiretroviral Drugs Using Plasma HIV RNA Measurements'' 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. Submit written comments concerning the draft
guidance to the Dockets Management Branch (HFA-305), Food and Drug
Administration, 5600 Fishers Lane, rm. 1061, Rockville, MD 20852.
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, 301-827-2495.
SUPPLEMENTARY INFORMATION: FDA is announcing the availability of a
draft guidance for industry entitled ``Clinical Considerations for
Accelerated and Traditional Approval of Antiretroviral Drugs Using
Plasma HIV RNA Measurements.'' The draft guidance summarizes the
scientific basis supporting the use of HIV RNA as a primary study
endpoint in both accelerated and traditional approvals of
antiretroviral drugs. This summary is based on scientific data
presented at a July 14 and 15, 1997, meeting of the Antiviral Drugs
Advisory Committee. At this meeting, there was expert consensus that
the use of plasma HIV RNA endpoints in certain situations could
reliably predict clinical benefit. The draft guidance suggests that
accelerated approvals could be based on studies that show a drug's
contribution toward shorter-term reductions in HIV RNA (e.g., 24 weeks)
while traditional approvals could be based on trials that show a drug's
contribution toward durability of HIV RNA suppression (e.g., at least
48 weeks) in lieu of a traditional clinical endpoint study. Changes in
CD4 cell counts should be consistent with observed HIV RNA changes when
considering approval of an antiretroviral drug.
The draft guidance describes the agency's current thinking on
clinical trial designs using HIV RNA changes as an endpoint for
accelerated and traditional approvals. Considerations regarding control
arms, study procedures, endpoints, and statistical methods for
analyzing HIV RNA endpoints are discussed. The draft guidance also
includes recommendations for sponsors who plan to use a new or
unapproved HIV RNA assay in a clinical study. When using such assays,
sponsors are encouraged to provide supporting data on the assay's
limits and performance characteristics as outlined in the last section
of the draft guidance.
This Level 1 draft guidance is being issued consistent with FDA's
good guidance practices (62 FR 8961, February 27, 1997). It represents
the agency's current thinking on certain aspects of antiretroviral drug
product
[[Page 47845]]
development for accelerated and traditional approval. 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.
Interested persons may, at any time, submit written comments on the
draft guidance to the Dockets Management Branch (address above). 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 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: August 20, 1999.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy.
[FR Doc. 99-22720 Filed 8-31-99; 8:45 am]
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