[Federal Register Volume 64, Number 22 (Wednesday, February 3, 1999)]
[Notices]
[Pages 5301-5302]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-2562]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 98D-1224]


Guidance for Industry on FDA Approval of New Cancer Treatment 
Uses for Marketed 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 guidance for industry entitled ``FDA Approval of New 
Cancer Treatment Uses for Marketed Drug and Biological Products.'' The 
guidance considers 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 guidance is part of an agency 
effort to encourage the submission of supplemental applications for new 
uses for approved drug and biological products. This guidance is 
consistent with the Food and Drug Administration Modernization Act of 
1997 (the Modernization Act), which specifies that the agency will 
continue its efforts to encourage sponsors to submit supplemental 
applications for new uses for their products.

DATES:  Written comments on agency guidance documents are welcome at 
any time.

ADDRESSES:  Copies of this guidance for industry are available on the 
Internet at ``http://www.fda.gov/cder/guidance/index.htm'' or ``http://
www.fda.gov/cber/guidelines.htm''. Submit written requests for single 
copies of this guidance to the Drug Information Branch (HFD-210), 
Center for Drug Evaluation and Research (CDER), Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857, or to the 
Office of Communication, Training, and Manufacturers Assistance (HFM-
40), Center for Biologics Evaluation and Research (CBER), 1401 
Rockville Pike, Rockville, MD 20852-1448. 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. Comments are to be identified with the 
docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT:  Robert L. Justice, Center for Drug

[[Page 5302]]

Evaluation and Research (HFD-150), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-594-2473.

SUPPLEMENTARY INFORMATION:  In the Federal Register of March 21, 1997 
(62 FR 13650), FDA published a draft guidance for industry entitled 
``Providing Clinical Evidence of Effectiveness for Human Drug and 
Biological Products'' as part of efforts to encourage the submission of 
supplemental applications for drug and biological products. The intent 
of that draft guidance was to clarify what clinical evidence of 
effectiveness should be provided in new drug applications and 
supplemental applications. On that same date, the agency published a 
draft guidance for industry entitled ``FDA Approval of New Cancer 
Treatment Uses for Marketed Drug and Biological Products,'' which 
considered 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. These guidances were published as part of agency 
efforts to expedite the development of new and supplemental uses for 
drug and biological products.
    In November 1997, the Modernization Act (Pub. L. 105-111) was 
signed into law by the President. Section 403 of the Modernization Act 
specifies that FDA will continue its efforts to encourage sponsors to 
submit supplemental applications for new uses for their products. 
Consistent with section 403 of the Modernization Act, the agency has 
finalized the draft guidances it issued in March 1997. After 
considering comments submitted by the public, FDA announced the 
availability, in final form, of the guidance entitled ``Providing 
Clinical Evidence of Effectiveness for Human Drug and Biological 
Products'' in the Federal Register of May 15, 1998 (63 FR 27093).
    This notice announces the availability of the final version of the 
guidance entitled ``FDA Approval of New Cancer Treatment Uses for 
Marketed Drug and Biological Products.'' This guidance focuses on the 
particular information to be provided when submitting an application 
for the approval of a supplemental new cancer treatment use for a 
marketed drug or therapeutic biological product. Cancer research often 
reveals potential new uses for already marketed drugs, and it is 
important to have new uses approved for inclusion in the product 
labeling as soon as adequate evidence of product safety and 
effectiveness for the new use becomes available.
    Consistent with section 403(c) of the Modernization Act, CDER and 
CBER have designated key persons who will: (1) Encourage the prompt 
review of supplemental applications for approved products, and (2) work 
with sponsors to facilitate the development and submission of data to 
support supplemental applications.
    Within CDER, the Associate Director for Medical Policy is 
fulfilling the requirements of section 403(c) of the Modernization Act 
by working with sponsors to facilitate the development of supplemental 
applications. Within the Division of Oncology Drug Products, the 
Special Assistant to the Division Director is working with sponsors to 
facilitate the development and submission of data to support 
supplemental applications for drug products used in cancer treatment. 
Efforts include: (1) Managing initiatives to seek the views of major 
groups and of individuals in the cancer research and treatment 
community, (2) managing and monitoring actions regarding possible 
labeling revisions, and (3) preparing regular progress reports.
    Within CBER, supplemental applications are being facilitated by the 
Deputy Director, Medical, in accordance with section 403(c) of the 
Modernization Act. Review activities for most oncologic product 
applications are managed by the Office of Therapeutics Research and 
Review. The Oncology Branch of the Division of Clinical Trials Design 
and Analysis will work with sponsors to facilitate the development and 
submission of data to support supplemental applications for biologics 
used in cancer treatment.
    This guidance represents the agency's current thinking on new 
cancer treatment uses for marketed drug and biological products. It 
does not create or confer any rights for or on any person and does not 
operate to bind FDA or the public in any way. An alternative approach 
may be used if such approach satisfies the requirements of the 
applicable statute, regulations, or both.

    Dated: January 27, 1999.
Jane E. Henney,
Commissioner of Food and Drugs.
[FR Doc. 99-2562 Filed 2-2-99; 8:45 am]
BILLING CODE 4160-01-F