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Guidance for Industry

Accelerated Approval Products —

Submission of Promotional Materials

DRAFT GUIDANCE

This guidance document is being distributed for comment purposes only.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publication in the Federal Register of the notice announcing the availability of the draft guidance.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 that publishes in the Federal Register.

For questions on the content of the draft document contact (CDER) Tracy L. Acker, 301-827-

2831 or (CBER) Toni M. Stifano, 301- 827-3028.

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)

March 1999

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Guidance for Industry

Accelerated Approval Products —

Submission of Promotional Materials

Additional copies of this Guidance are available from:

 Office of Training and Communications

 Division of Communications Management 

Drug Information Branch, HFD-210

Center for Drug Evaluation and Research

Food and Drug Administration

 5600 Fishers Lane, Rockville, MD 20857 

(Phone 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

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)

March 1999

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TABLE OF CONTENTS

I. INTRODUCTION ..................................................... 1

II. BACKGROUND ...................................................... 1

III. COMMUNICATING WITH FDA DURING THE

PREAPPROVAL REVIEW PERIOD ...................................... 2

IV. PROMOTIONAL MATERIALS INTENDED FOR USE DURING THE 120-DAY

POSTMARKETING PERIOD ............................................ 2

A. General Requirements for Submission and Review ....................... 2

B. Submissions During the 120 Day Post Approval Period ................... 3

V. PROMOTIONAL MATERIALS INTENDED FOR USE FOLLOWING THE

 120-DAY POSTAPPROVAL PERIOD .................................... 3

VI. TERMINATING SUBMISSION REQUIREMENTS .......................... 4
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This guidance has been prepared by the Division of Drug Marketing, Advertising, and Communications in 1

the Center for Drug Evaluation and Research (CDER) in consultation with the Center for Biologics Evaluation and

Research (CBER) at the Food and Drug Administration. This 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 requirements of the applicable statute, regulations, or both. 

Sponsors whose drug or biological product is in a fast track program that is eligible for approval under 2

section 506(b) of the Federal Food, Drug, and Cosmetic Act are also subject to 314.550 and 601.45 and can use these

procedures. 

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GUIDANCE FOR INDUSTRY1

Accelerated Approval Products —

Submission of Promotional Materials

I. INTRODUCTION

This guidance is intended to describe procedures that sponsors of human prescription drug and

biological products can use to submit promotional materials to the Center for Drug Evaluation

and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) under 21

CFR 314.550 and 601.45 for products approved under the accelerated approval regulations .

2

In the context of this draft guidance, the term promotional materials includes promotional

labeling and advertisements. Examples of labeling include, but are not limited to, brochures,

booklets, detailing pieces, bulletins, calendars, motion pictures, and slides (21 CFR 202.1(l)(2)). 

Advertisements include, but are not limited to, materials published in journals, magazines, other

periodicals, and newspapers, and advertisements broadcast through media such as radio,

television, and telephone communications systems (§ 202.1(l)(1)).

II. BACKGROUND

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. The accelerated approval regulations require

that, unless otherwise informed by the Agency, applicants submit to FDA copies of all

promotional materials, including promotional labeling and advertisements, intended for
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dissemination or publication within the first 120 days following marketing approval during the

preapproval review period (see 21 CFR 314.550 and 601.45). The regulations require further

that promotional materials intended for dissemination any time after the 120-day postapproval

period be submitted at least 30 days prior to the intended date of initial dissemination or

publication of those materials, unless otherwise informed by the Agency. 

III. COMMUNICATING WITH FDA DURING THE PREAPPROVAL REVIEW

PERIOD 

To the extent that a sponsor anticipates approval of a product under the accelerated approval

provisions, FDA encourages sponsors to begin communication with the appropriate division early

in the application review process regarding submission of draft promotional materials for review

during the preapproval period. Sponsors should contact CDER, Division of Drug Marketing,

Advertising, and Communications (DDMAC) or CBER, Advertising and Promotional Labeling

Staff (APLS), Office of Compliance and Biologics Quality. Early communication with DDMAC

or APLS should enable the sponsor to understand and comply with the submission requirements

prior to product approval or licensing.

IV. PROMOTIONAL MATERIALS INTENDED FOR USE DURING THE 120-DAY

POSTMARKETING PERIOD

A. General Requirements for Submission and Review

As previously noted, unless otherwise informed by FDA, applicants must submit to the

Agency copies of all promotional materials, including promotional labeling and

advertisements, intended for dissemination or publication within 120 days following

marketing approval prior to approval or licensing (21 CFR 314.550 and 601.45). FDA’s

goal is to provide comments in a timely manner, usually within 15 working days of the day

the materials are received by DDMAC or APLS. The Agency expects that materials will

not be disseminated or published until the Agency’s objections are resolved. FDA

recommends that the applicant plan sufficient time for resolving differences with the

Agency concerning the submitted materials prior to dissemination or publication.

In some cases, the sponsor may respond to the Agency’s comments on previously

submitted materials after product approval. However, FDA expects that no promotional

materials will be disseminated until the Agency’s concerns have been resolved. 

To the extent that product labeling is not yet final, a sponsor may be unable to provide

FDA with final promotional materials prior to product approval. In such instances, the
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Agency may be able to comment on many of the important aspects of the promotion based

upon draft promotional materials. 

B. Submissions During the 120 Day Post Approval Period

FDA expects that all promotional materials intended for use during the 120-day

postapproval period will be submitted prior to product approval. However, FDA

recognizes that, on rare occasions, the following circumstances may preclude a sponsor

from submitting every promotional item intended for use during the 120 day postapproval

period prior to approval:

i. The designation of accelerated approval status occurs late in the preapproval

review period or extensive and substantive changes to draft labeling occur so late

that completely new promotional materials need to be developed. Under such

circumstances, the sponsor should still submit as many materials as possible before

approval.

ii. A sponsor may need to address unforeseen problems or report information in

labeling material that is beneficial to fostering the safe and effective use of the

product after it has entered the marketplace. For example, a sponsor may have to

address an unforeseen problem with product administration or availability, or an

unexpectedly high incidence of an adverse event. Sponsors can request that FDA

review such additional materials and should provide a rationale for distribution of

these materials prior to submission of the actual materials. FDA will respond to

such requests in a timely manner and, when appropriate, will provide comments on

the materials.

V. PROMOTIONAL MATERIALS INTENDED FOR USE FOLLOWING THE 120-

DAY POSTAPPROVAL PERIOD 

Promotional materials intended for use following the 120 day postapproval period must be

submitted to FDA for review at least 30 days prior to its intended dissemination or publication

date, unless otherwise informed by the Agency (21 CFR 314.550 and 601.45). FDA requests that

sponsors consider batching these submissions, rather than submitting multiple individual pieces. 

Batching will facilitate a more expeditious review. Sponsors may submit such materials for

review as early as 90 days post approval (30 days prior to intended dissemination or publication). 

However, such materials should not be used until the Agency’s concerns are resolved and until

the 120 day postapproval period has expired. 
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Submissions should be made under cover of a letter to DDMAC or APLS requesting comments

on draft materials, referencing the materials are being submitted pursuant to 21 CFR 314.550 or

601.45, and should include copies of draft materials and all supporting references necessary for

FDA review.

FDA intends to provide the sponsor with comments as soon as possible. If the Agency notifies

the sponsor of significant objections to the proposed materials, the Agency expects that these

materials will not be disseminated or published until the Agency’s concerns have been resolved.

Sponsors often develop promotional materials that are derivative of previously reviewed materials

(i.e., materials that present product claims and representations of the same content and context as

previously reviewed materials) for use after the 120-day postapproval period. These materials

should also be submitted for review prior to use. FDA intends to review and comment on

derivative materials in a timely manner, usually within 15 working days of the day the materials

are received by FDA.

At the time of initial dissemination or publication, sponsors are required to submit final materials

for drug products under cover of FDA Form 2253, pursuant to 21 CFR 314.81(b)(3)(i) and for

biological products under cover of FDA Form 2567 or equivalent pursuant to 21 CFR

601.12(f)(4).

VI. TERMINATING SUBMISSION REQUIREMENTS

Under 21 CFR 314.560 and 601.46, FDA may determine after approval that the requirements

established in §§ 314.550 and 601.45 are no longer necessary for the safe and effective use of a

drug or biological product. If this happens, the Agency will notify the applicant in writing that

advanced submission of promotional materials is no longer required. For human prescription

drugs, the applicant will be notified by DDMAC in CDER. For biological products, the applicant

will be notified by APLS in CBER.
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