[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Draft Guidance for Industry: Providing Clinical Evidence of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availability of a draft guidance entitled, ``Guidance for Industry: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 The purpose of the draft guidance is to clarify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 The draft guidance is part of the agency's ``New Use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Federal Register, FDA is announcing the availability of a draft
guidance that discusses the quality and quantity of data that may be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on the draft guidance.
DATES: Written comments on the draft guidance by May 20, 1997.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ADDRESSES: Submit written requests for single copies of the draft
guidance entitled ``Guidance for Industry: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draft guidance also may be obtained by mail by calling the CBER Voice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
