[Federal Register: March 26, 1999 (Volume 64, Number 58)]
[Notices]
[Page 14735-14736]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26mr99-116]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 99D-0484]


Draft Guidance for Industry on Accelerated Approval Products:
Submission of Promotional Materials; 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availability of a draft guidance for industry entitled ``Accelerated
Approval Products: Submission of Promotional Materials.'' The
accelerated approval regulations require that applicants, unless
otherwise informed by the agency, submit to FDA for consideration
during the preapproval review period copies of all promotional
materials, including promotional labeling and advertisements, intended
for dissemination or publication within 120 days following marketing
approval. This draft guidance is intended to assist sponsors of drug
and biological products who are submitting such materials as part of
the accelerated approval process.

[[Page 14736]]

DATES: Written comments on the draft guidance may be submitted by May
26, 1999. General comments on agency guidance documents are welcome at
any time.

ADDRESSES: Copies of this draft guidance are available on the Internet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copies of the draft guidance for industry to the Drug Information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 Submit written comments on the draft guidance to the Dockets
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852, or FAX 301-594-3215.

FOR FURTHER INFORMATION CONTACT:
    Regarding prescription human drugs: Tracy L. Acker, Center for Drug
Evaluation and Research (HFD-40), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-2831, or via Internet at
ackert@cder.fda.gov.
    Regarding biological products: Toni M. Stifano, Center for
Biologics Evaluation and Research (HFM-202), Food and Drug
Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-827-
3028, or via Internet at stifano@cber.fda.gov.

SUPPLEMENTARY INFORMATION: FDA is announcing the availability of a
draft guidance for industry entitled ``Accelerated Approval Products:
Submission of Promotional Materials.'' This draft guidance is intended
to assist sponsors of drug and biological products who are submitting
promotional materials as part of the accelerated approval process.
     In the Federal Register of December 11, 1992 (57 FR 58942), FDA
published final regulations under which the agency would accelerate the
approval of certain new drugs and biological products for serious or
life-threatening illnesses. In November 1997, the President signed the
Food and Drug Administration Modernization Act of 1997 (the
Modernization Act) (Pub. L. 105-115). Section 112 of the Modernization
Act, in part, essentially codified in statute the accelerated approval
regulations in an amendment to the Federal Food, Drug, and Cosmetic Act
(section 506 of the act (21 U.S.C. 356) entitled ``Fast Track
Products''). On November 12, 1998, FDA published a draft guidance for
industry on its policies and procedures regarding fast track drug
development programs. The draft guidance that is the subject of this
notice would apply to all products approved under Sec. 314.500 (21 CFR
314.500), including those designated as fast track development
programs.
     Among other things, the accelerated approval regulations
(Secs. 314.550 and 601.45 (21 U.S.C. 314.550 and 601.45)) require that
applicants, unless otherwise informed by the agency, submit to FDA for
consideration during the preapproval review period copies of all
promotional materials, including promotional labeling as well as
advertisements, intended for dissemination or publication during the
120 days following marketing approval. The accelerated approval
regulations also require that promotional materials intended for use
following the 120-day postapproval period must be submitted to FDA for
review at least 30 days prior to the intended time of initial
dissemination of the labeling or initial publication of the
advertisement, unless otherwise informed by the agency.
     During the past several years, representatives of the
pharmaceutical industry have requested guidance from FDA on the
procedures for submitting promotional materials under Secs. 314.550 and
601.45. The draft guidance is intended to assist applicants submitting
promotional materials under these regulations.
     This draft guidance document represents the agency's current
thinking on the process for submitting promotional materials for
accelerated approval products. 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
requirement of the applicable statute, regulations, or both.
     Interested persons may, on or before May 26, 1999, submit to the
Dockets Management Branch (address above) written comments on the draft
guidance. Two copies of any comments are to be submitted, except that
individuals may submit one copy. Comments or requests for copies 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 office above between 9 a.m. and
4 p.m., Monday through Friday.

    Dated: March 19, 1999.
 William K. Hubbard,
 Acting Deputy Commissioner for Policy.
[FR Doc. 99-7516 Filed 3-25-99; 8:45 am]
BILLING CODE 4160-01-F