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Guidance for Industry

Providing Regulatory Submissions in

Electronic Format —

Prescription Drug Advertising and

Promotional Labeling

Draft Guidance

This guidance document is being distributed for comment purposes only.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 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
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Guidance for Industry

Providing Regulatory Submissions in

Electronic Format —

Prescription Drug Advertising and

Promotional Labeling

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

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
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TABLE OF CONTENTS

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

II. GENERAL ISSUES ............................................................................................................................................................1

A. SCOPE................................................................................................................................................................................. 1

B. ELECTRONIC SIGNATURES.............................................................................................................................................. 2

C. MIXED SUBMISSIONS — ELECTRONIC AND PAPER..................................................................................................... 3

D. GENERAL INFORMATION ON LOGISTICS OF SENDING ELECTRONIC SUBMISSIONS................................................. 3

III. ORGANIZING THE MAIN FOLDER .........................................................................................................................3

A. FOLDERS............................................................................................................................................................................ 3

B. OPTIONAL COVER LETTER.............................................................................................................................................. 3

C. FORMS FDA 2253 AND 2567.......................................................................................................................................... 3

D. CURRENT LABELING TEXT ............................................................................................................................................. 4

E. TABLE OF CONTENTS....................................................................................................................................................... 4

F. ROADMAP .PDF FILE (CBER ONLY)............................................................................................................................... 4

IV. ORGANIZING THE ELECTRONIC SUBMISSION..............................................................................................5

A. PROMOTIONAL MATERIALS............................................................................................................................................. 5

B. REFERENCES...................................................................................................................................................................... 5
Draft — Not for Implementation

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Guidance for Industry11

2 Providing Regulatory Submissions in Electronic Format —

3

4 Prescription Drug Advertising and Promotional Labeling

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20 I. INTRODUCTION

21

22 This is one in a series of guidance documents intended to assist applicants making regulatory

23 submissions in electronic format to the Center for Drug Evaluation and Research (CDER) and

24 the Center for Biologics Evaluation and Research (CBER), Food and Drug Administration

25 (FDA). This specific guidance discusses issues related to the electronic submission of

26 advertising and promotional labeling materials for prescription drug and biological products,

27 including launch materials. In some cases, guidance differs from CDER to CBER because of

28 differences in the procedures and computer infrastructure in the centers. We will work to

29 minimize these differences wherever possible. Agency guidance documents on electronic

30 submissions will be updated regularly to reflect the evolving nature of the technology and the

31 experience of those using this technology.

32 For a list of guidances that are under development on electronic submissions, see

33 Regulatory Submissions in Electronic Format — General Considerations (January 1999). The

34 General Considerations guidance also addresses issues, such as file formats, media, and

35 submission procedures, that are common to all submission types.

36

37 II. GENERAL ISSUES

38

39 A. Scope

40

41 This guidance addresses the submission of the following materials.

 

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.

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.
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42

43 1. Advertisements and promotional labeling submitted under 21 CFR 314.81(b)(3)(i) or

44 601.12(f)(4) as part of the postmarketing reporting regulations for approved

applications with either Forms FDA 2253 (CDER or CBER) or 2567 (CBER).2 45

46 These regulations provide general requirements for submitting advertising and

47 promotional labeling material to CDER and CBER at the time of publication of an

48 advertisement, and at the time of initial dissemination of promotional labeling.

49

50 2. Proposed advertisements and promotional labeling planned for use in a medical

51 product’s launch campaign voluntarily submitted as a request for comment and other

52 proposed materials voluntarily submitted with a request for comment

53

54 • CBER — All submissions to CBER should be accompanied by Part I of either

55 Form 2567 or 2253, as appropriate.

56

57 • CDER — Materials submitted voluntarily to CDER should not be

58 accompanied by Form 2567 or 2253.

59

60 3. Advertisements and promotional labeling submitted under the requirements of 21

61 CFR 314.550 and 21 CFR 601.45 as part of the accelerated approval requirements

and restricted distribution for drug and biological products3 62

63

64 • CBER - Materials should be submitted to CBER with either Form FDA 2253

65 or 2567 (Part I or II), as appropriate, to aid in tracking.

66

67 • CDER - After publishing the advertising or disseminating the promotional

68 labeling, these promotional materials should be submitted as described in A.

69 1. above.

70

71 4. Requests for comment on materials for the development of evidence to support future

72 advertising or promotional labeling claims (i.e., health-related quality of life

73 outcomes)

74

5. Submissions under 21 CFR Part 994 75 of materials regarding the dissemination of

76 information on unapproved/new uses for drugs, biological products and devices

77

78 B. Electronic Signatures

79

80 The Agency is developing procedures for archiving documents with electronic signatures. Until

81 those procedures are in place, we will not be able to accept electronic signatures in place of hand

 

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.

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 The Food and Drug Administration Modernization Act of 1997, section 401.
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82 written signatures. This means that for documents requiring a handwritten signature (e.g.,

83 certifications), you should include a paper version with the hand written signature along with the

84 electronic version.

85

86 C. Mixed Submissions — Electronic and Paper

87

88 If you decide to submit advertisements and promotional labeling materials in electronic format,

89 the entire submission should be in electronic format. We prefer that all subsequent submissions

90 related to the initial submission be in electronic format.

91

92 D. General Information on Logistics of Sending Electronic Submissions

93

94 You can find general information on the logistics of sending electronic submissions in guidance

95 for industry, Providing Regulatory Submissions in Electronic Format – General Considerations

96 (January 1999).

97

98

99 III. ORGANIZING THE MAIN FOLDER

100

101 All documents should be placed in a main folder using the NDA, IND, or BLA number (e.g.,

102 N123456, I123456, or B123456, respectively) as the folder name.

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104 A. Folders

105

106 Inside the main folder, you should include two folders, promo and refs, to organize the files

107 supporting the submission. The promotional material(s) and supporting reference(s) should be

108 placed in the promo and refs folders, respectively.

109

110 B. Optional Cover Letter

111

112 If you decide you would like to provide a cover letter with additional information, such as the

113 materials needing priority reviews and a technology point of contact, the cover letter should be

114 provided as a portable document format (PDF) file named cover.pdf inside the main folder.

115

116 This cover letter is not a substitute for requested FDA forms for CBER. For example, if you

117 wish to voluntarily submit advertising and promotional labeling material for comment to CBER,

118 you should continue to submit Part I of FDA Forms 2567 or 2253 in addition to a cover letter.

119

120 C. Forms FDA 2253 and 2567

121

122 When submitting Form FDA 2253 or 2567, you should provide it as a PDF file named 2253.pdf

123 or 2567.pdf inside the main folder. Until the Agency is prepared to receive electronic signatures,

124 a signed paper Form FDA 2253 or 2567 should accompany the promotional material submitted

125 under 21 CFR 314.81(b)(3).

126
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127 D. Current Labeling Text

128

129 You should provide a copy of the currently used labeling text as a PDF file named current.pdf in

130 the main folder. The currently used labeling text may differ from the most recent approved

131 labeling text under the provisions of 21 CFR 314.70 and 21 CFR 314.81(b)(2). In the case of

132 submissions provided prior to approval, you should submit the most recent draft labeling text.

133

134 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.5 135 You should generate the

136 PDF file for the labeling text from electronic source documents and not from scanned material.

137

138 E. Table of Contents

139

140 Inside the main folder, you should provide a table of contents for the submission named toc.pdf.

141 You should supply a hypertext link to the corresponding file. For an example, see Table 1.

142

143 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

List promotional material starting here

References Refs

List references starting here

144

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146

147 F. Roadmap.pdf File (CBER only)

148

149 The root directory of the electronic submission should contain a roadmap.pdf file to

150 orient reviewers to the original submission of promotional materials as well as any

151 subsequent information.

152 The roadmap.pdf file should contain a hypertext link to the submission’s main table of

153 contents. The roadmap should be updated and resubmitted as additional information is

154 supplied in support of the prescription drug advertising or promotional labeling

155 submission.

156 The roadmap file should not contribute in any way to the content of your submission. It

157 is a map, intended to facilitate navigation through the contents of the submission. The

 

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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158 submission’s roadmap.pdf file should be easily updated or modified using the Replace

159 file command under the Document menu option in Adobe Acrobat. This function will

160 automatically replace the hypertext links to previously submitted information, leaving

161 only the task of creating new hypertext links to the newly submitted information.

162 In addition to providing a navigable guide to your submission, the roadmap.pdf file

163 should include the sponsor’s submission date in the DD-MM-YYYY format (e.g., 01-

164 Jan-1999). The contents of the submission and of its subsequent amendments should be

165 briefly described in a roadmap.pdf table.

166

167

168 IV. ORGANIZING THE ELECTRONIC SUBMISSION

169

170 The submission should include the promotional materials and supporting documents. The

171 guidance for providing these items in electronic format follows.

172

173 A. Promotional materials

174

175 You should provide each promotional piece as an individual PDF file. For three-dimensional

176 objects, you should provide a digital image of the object in sufficient detail to allow us to review

177 the promotional material. In addition, you should provide information adequate to determine the

178 size of the object (i.e., point size, dimensions). You should place all promotional material PDF

179 files in the folder named promo.

180

181 B. References

182

183 You should provide each reference as an individual PDF file and highlight the sections of the full

184 reference that you refer to in the promotional material. You should place these files in the folder

185 named refs. When ever possible, you should generate the PDF files from electronic source

186 documents and not from scanned material.

187

188 When a reference is used to support a claim in proposed promotional materials voluntarily

189 submitted for advisory opinion or Agency comment, you should provide a hypertext link to the

190 page of the reference or labeling that contains the supporting information.

191

192 For promotional materials submitted as part of the postmarketing reporting requirements, you

193 can also provide hypertext links to references or labeling.

194