99-22720. Draft Guidance for Industry on Clinical Considerations for Accelerated and Traditional Approval of Antiretroviral Drugs Using Plasma HIV RNA Measurements; Availability  

  • [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    Draft Guidance for Industry on Clinical Considerations for 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    availability of a draft guidance for industry entitled ``Clinical 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 The draft 
    guidance is intended to assist pharmaceutical sponsors in the 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    DATES: Written comments on the draft guidance may be submitted by 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    ADDRESSES: Copies of the draft guidance for industry are available on 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    written requests for single copies of the draft guidance entitled 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 Submit written comments concerning the draft 
    guidance to the Dockets Management Branch (HFA-305), Food and Drug 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]
    BILLING CODE 4160-01-F
    
    
    

Document Information

Published:
09/01/1999
Department:
Food and Drug Administration
Entry Type:
Notice
Action:
Notice.
Document Number:
99-22720
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.
Pages:
47844-47845 (2 pages)
Docket Numbers:
Docket No. 99D-2445
PDF File:
99-22720.pdf