[Federal Register Volume 62, Number 55 (Friday, March 21, 1997)]
[Notices]
[Pages 13650-13651]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-7133]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 97D-0100]


Draft Guidance for Industry: Providing Clinical Evidence of 
Effectiveness for Human Drug and Biological Products; 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availability of a draft guidance entitled, ``Guidance for Industry: 
Providing Clinical Evidence of Effectiveness for Human Drug and 
Biological Products.'' The purpose of the draft guidance is to clarify 
what clinical evidence of effectiveness should be provided in new drug 
applications, biological product license applications, and supplemental 
applications. The draft guidance is part of the agency's ``New Use 
Initiative--Evidence for Primary and Supplemental Approvals,'' which is 
exploring ways to expedite the development of new and supplemental uses 
for drug and biological products. Elsewhere in this issue of the 
Federal Register, FDA is announcing the availability of a draft 
guidance that discusses the quality and quantity of data that may be 
adequate to add a new use to the prescribing information for a product 
used in the treatment of cancer. The agency is seeking public comment 
on the draft guidance.

DATES: Written comments on the draft guidance by May 20, 1997. General 
comments on agency guidance documents may be submitted at any time.

ADDRESSES: Submit written requests for single copies of the draft 
guidance entitled ``Guidance for Industry:

[[Page 13651]]

Providing Clinical Evidence of Effectiveness for Human Drug and 
Biological Products'' to the Drug Information Branch (HFD-210), Center 
for Drug Evaluation and Research, Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857; or the Office of Communication, 
Training and Manufacturers Assistance (HFM-40), Center for Biologics 
Evaluation and Research (CBER), Food and Drug Administration, 1401 
Rockville Pike, Rockville, MD 20852-1448. Send two self-addressed 
adhesive labels to assist the offices in processing your requests. The 
draft guidance also may be obtained by mail by calling the CBER Voice 
Information System at 1-800-835-4709 or 301-827-1800, or by facsimile 
by calling the FAX Information System at 1-800-835-4709 or 301-827-
1800. See the SUPPLEMENTARY INFORMATION section for electronic access 
to the draft guidance. Submit written comments on the draft guidance to 
the Dockets Management Branch (HFA-305), Food and Drug Administration, 
12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Joseph P. Griffin, Center for Drug 
Evaluation and Research (HFD-5), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-594-5400.

SUPPLEMENTARY INFORMATION: 

I. Background

    When drugs approved for one use prove safe and effective for 
treating other conditions, information on the new use should be added 
to the product labeling as soon as possible. FDA is exploring ways to 
expedite the development of new and supplemental uses of drug and 
biological products. The agency believes it can improve the approval 
process and increase the number of safe and effective new uses being 
added to drug labeling by doing the following: (1) Clarifying what 
evidence should be provided in primary and supplemental applications 
and (2) working with industry to reduce barriers to submitting 
applications for new uses for their products.
    Because some of the information submitted in a supplemental 
application may be available from the primary application, the agency 
decided that its first step would be to clarify what information 
sponsors should provide in applications in general. The draft guidance 
entitled, ``Guidance for Industry: Providing Clinical Evidence of 
Effectiveness for Human Drug and Biological Products'' discusses the 
clinical evidence that should be provided when submitting a new drug or 
biological product license application or a supplemental application 
for a new use of a drug or biological product.
    Elsewhere in this issue of the Federal Register, FDA is announcing 
the availability of a second draft guidance entitled, ``Guidance for 
Industry: FDA Approval of New Cancer Treatment Uses for Marketed Drug 
and Biological Products.'' The draft guidance focuses on the quality 
and quantity of data that may be adequate to add a new use to the 
prescribing information for a product used in the treatment of cancer. 
Cancer treatments often yield potential new uses for marketed drug 
products.
    Although this guidance does not create or confer any right on any 
person , and does not operate to bind FDA in any way, it does represent 
the agency's current thinking on clinical evidence of effectiveness for 
human drug and biological products.

II. Request for Comments

    Interested parties may 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 may be seen in the office above between 9 a.m. and 4 
p.m., Monday through Friday.

III. Electronic Access

    An electronic version of this draft guidance also is available via 
Internet using the World Wide Web (WWW) (connect to the CDER home page 
at http://www.fda.gov/cder and go to the ``Regulatory Guidance'' 
section, or to the CBER home page at http://www.fda.gov/cber/
cberftp.html).

    Dated: March 14, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-7133 Filed 3-20-97; 8:45 am]
BILLING CODE 4160-01-F