[Federal Register Volume 64, Number 58 (Friday, March 26, 1999)]
[Notices]
[Pages 14735-14736]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-7516]


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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Draft Guidance for Industry on Accelerated Approval Products: 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availability of a draft guidance for industry entitled ``Accelerated 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 This draft guidance is intended to assist sponsors of drug 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DATES: Written comments on the draft guidance may be submitted by May 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ADDRESSES: Copies of this draft guidance are available on the Internet 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copies of the draft guidance for industry to the Drug Information 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 Submit written comments on the draft guidance to the Dockets 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 
[email protected].
    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 [email protected].

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