[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