Guidance for Industry
Providing Regulatory
Submissions in Electronic Format - Prescription Drug Advertising
and Promotional Labeling
Draft Guidance
[Acrobat version of this document]
This guidance document is being
distributed for comment purposes only.
Comments and suggestions regarding this draft document
should be submitted within 60 days of publication in the Federal Register of the
notice announcing the availability of the draft guidance. Submit comments to Dockets
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket number listed in
the notice of availability published in the Federal Register.
For questions regarding this draft document contact (CDER)
Warren Rumble, 301-827-2831, or (CBER) Michael Fauntleroy, 301-827-5101.
U.S. Department of Health and Human
Services
Food and Drug Administration
Center for Drug Evaluation and Research
(CDER)
Center for Biologics Evaluation and
Research (CBER)
January 2001
IT
Additional copies are available from:
Office of Training and Communications
Division of Communications Management
Drug Information Branch, HFD-210
5600 Fishers Lane
Rockville, MD 20857
(Tel) 301-827-4573
(Internet) http://www.fda.gov/cder/guidance/index.htm
or
Office of Communication, Training and
Manufacturers Assistance, HFM-40
Center for Biologics Evaluation and
Research
Food and Drug Administration
1401 Rockville Pike, Rockville, MD
20852-1448
Internet: http://www.fda.gov/cber/guidelines.htm.
Fax: 1-888-CBERFAX or 301-827-3844
Mail: the Voice Information System at
800-835-4709 or 301-827-1800
IT
TABLE OF CONTENTS
I. INTRODUCTION
II. GENERAL ISSUES
III. ORGANIZING THE MAIN FOLDER
IV. ORGANIZING THE ELECTRONIC SUBMISSION
Guidance for Industry1
Providing Regulatory
Submissions in Electronic Format -
Prescription Drug Advertising
and Promotional Labeling
This draft guidance, when finalized, will represent the
Food and Drug Administration's current thinking on this topic. 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 requirements of the
applicable statutes and regulations.
I. INTRODUCTION
This is one in a series of guidance documents intended to
assist applicants making regulatory submissions in electronic format to the Center for
Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research
(CBER), Food and Drug Administration (FDA). This specific guidance discusses issues
related to the electronic submission of advertising and promotional labeling materials for
prescription drug and biological products, including launch materials. In some cases,
guidance differs from CDER to CBER because of differences in the procedures and computer
infrastructure in the centers. We will work to minimize these differences wherever
possible. Agency guidance documents on electronic submissions will be updated regularly to
reflect the evolving nature of the technology and the experience of those using this
technology.
For a list of guidances that are under development on
electronic submissions, see
Regulatory Submissions in Electronic Format - General
Considerations (January 1999). The General Considerations guidance also addresses
issues, such as file formats, media, and submission procedures, that are common to all
submission types.
II. GENERAL ISSUES
This guidance addresses the submission of the following
materials.
1. Advertisements and promotional labeling submitted under
21 CFR 314.81(b)(3)(i) or 601.12(f)(4) as part of the postmarketing reporting regulations
for approved applications with either Forms FDA 2253 (CDER or CBER) or 2567 (CBER).2
These regulations provide general requirements for
submitting advertising and promotional labeling material to CDER and CBER at the time of
publication of an advertisement, and at the time of initial dissemination of promotional
labeling.
2. Proposed advertisements and promotional labeling
planned for use in a medical product's launch campaign voluntarily submitted as a request
for comment and other proposed materials voluntarily submitted with a request for comment
· CBER - All submissions to CBER should be accompanied by
Part I of either Form 2567 or 2253, as appropriate.
· CDER - Materials submitted voluntarily to CDER should
not be accompanied by Form 2567 or 2253.
3. Advertisements and promotional labeling submitted under
the requirements of 21 CFR 314.550 and 21 CFR 601.45 as part of the accelerated approval
requirements and restricted distribution for drug and biological products3
· CBER - Materials should be submitted to CBER with
either Form FDA 2253 or 2567 (Part I or II), as appropriate, to aid in tracking.
· CDER - After publishing the advertising or
disseminating the promotional labeling, these promotional materials should be submitted as
described in A. 1. above.
4. Requests for comment on materials for the development
of evidence to support future advertising or promotional labeling claims (i.e.,
health-related quality of life outcomes)
5. Submissions under 21 CFR Part 994 of materials regarding the dissemination of
information on unapproved/new uses for drugs, biological products and devices
B. Electronic Signatures
The Agency is developing procedures for archiving
documents with electronic signatures. Until those procedures are in place, we will not be
able to accept electronic signatures in place of hand written signatures. This means that
for documents requiring a handwritten signature (e.g., certifications), you should include
a paper version with the hand written signature along with the electronic version.
If you decide to submit advertisements and promotional
labeling materials in electronic format, the entire submission should be in electronic
format. We prefer that all subsequent submissions related to the initial submission be in
electronic format.
You can find general information on the logistics of
sending electronic submissions in guidance for industry, Providing Regulatory
Submissions in Electronic Format - General Considerations (January 1999).
III. ORGANIZING THE MAIN FOLDER
All documents should be placed in a main folder using the
NDA, IND, or BLA number (e.g., N123456, I123456, or B123456, respectively) as the folder
name.
Inside the main folder, you should include two folders, promo
and refs, to organize the files supporting the submission. The promotional
material(s) and supporting reference(s) should be placed in the promo and refs
folders, respectively.
If you decide you would like to provide a cover letter
with additional information, such as the materials needing priority reviews and a
technology point of contact, the cover letter should be provided as a portable document
format (PDF) file named cover.pdf inside the main folder.
This cover letter is not a substitute for requested FDA
forms for CBER. For example, if you wish to voluntarily submit advertising and promotional
labeling material for comment to CBER, you should continue to submit Part I of FDA Forms
2567 or 2253 in addition to a cover letter.
When submitting Form FDA 2253 or 2567, you should provide
it as a PDF file named 2253.pdf or 2567.pdf inside the main folder. Until
the Agency is prepared to receive electronic signatures, a signed paper
Form FDA 2253 or 2567 should accompany the promotional material submitted under 21 CFR
314.81(b)(3).
You should provide a copy of the currently used labeling
text as a PDF file named current.pdf in the main folder. The currently used
labeling text may differ from the most recent approved labeling text under the provisions
of 21 CFR 314.70 and 21 CFR 314.81(b)(2). In the case of submissions provided prior to
approval, you should submit the most recent draft labeling text.
The labeling text is the content and format of labeling as
defined in 21 CRF 201.56 and 201.57 and includes all text, tables, and figures used in the
package insert.5 You should generate
the PDF file for the labeling text from electronic source documents and not from scanned
material.
Inside the main folder, you should
provide a table of contents for the submission named toc.pdf. You should supply a
hypertext link to the corresponding file. For an example, see Table
1.
Table 1: Example Table of
Contents for a Submission
Description |
Folder/file name |
Form FDA 2253 |
Main/2253.pdf |
Cover letter |
Main/cover.pdf |
Current labeling |
Main/current.pdf |
Promotional material |
Promo |
|
|
References |
Refs |
|
|
The root directory of the electronic submission should
contain a roadmap.pdf file to orient reviewers to the original submission of
promotional materials as well as any subsequent information.
The roadmap.pdf file should contain a hypertext
link to the submission's main table of contents. The roadmap should be updated and
resubmitted as additional information is supplied in support of the prescription drug
advertising or promotional labeling submission.
The roadmap file should not contribute in any way to the
content of your submission. It is a map, intended to facilitate navigation through the
contents of the submission. The submission's roadmap.pdf file should be easily
updated or modified using the Replace file command under the Document menu
option in Adobe Acrobat. This function will automatically replace the hypertext links to
previously submitted information, leaving only the task of creating new hypertext links to
the newly submitted information.
In addition to providing a navigable guide to your
submission, the roadmap.pdf file should include the sponsor's submission date in
the DD-MM-YYYY format (e.g., 01-Jan-1999). The contents of the submission and of its
subsequent amendments should be briefly described in a roadmap.pdf table.
IV. ORGANIZING THE ELECTRONIC
SUBMISSION
The submission should include the promotional materials
and supporting documents. The guidance for providing these items in electronic format
follows.
You should provide each promotional piece as an individual
PDF file. For three-dimensional objects, you should provide a digital image of the object
in sufficient detail to allow us to review the promotional material. In addition, you
should provide information adequate to determine the size of the object (i.e., point size,
dimensions). You should place all promotional material PDF files in the folder named promo.
You should provide each reference as an individual PDF
file and highlight the sections of the full reference that you refer to in the promotional
material. You should place these files in the folder named refs. When ever
possible, you should generate the PDF files from electronic source documents and not from
scanned material.
When a reference is used to support a claim in proposed
promotional materials voluntarily submitted for advisory opinion or Agency comment, you
should provide a hypertext link to the page of the reference or labeling that contains the
supporting information.
For promotional materials submitted as part of the
postmarketing reporting requirements, you can also provide hypertext links to references
or labeling.
1 This
guidance has been prepared by the Center for Drug Evaluation and Research (CDER) and the
Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration.
2 Forms
FDA 2253 and 2567 can be found at http://aosweb.psc.dhhs.gov/forms/fdaforms.htm.
3 In March 1999,
the Agency issued a draft guidance titled Accelerated Approval Products - Submission of
Promotional Materials (March1999), which will reflect the Agency's views on this
topic, once it has been finalized.
4 The Food and
Drug Administration Modernization Act of 1997, section 401.
5 See
guidance for industry, Providing Regulatory Submissions in Electronic Format -
NDAs (January 1999) and Providing Regulatory Submissions to the Center for
Biologics Evaluation and Research (CBER) in Electronic Format-Biologics Marketing
Applications (November 1999) for additional details on providing the currently
used labeling text.
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Guidance Page
FDA/Center for Drug Evaluation and Research
Last Updated: March 08, 2001
Originator: OTCOM/DLIS
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