FDA PDF Version 3.1 说明(3)

2019-08-30 21:41

Adobe Acrobat 裡面還有提供一個「為快速Web檢視最佳化PDF」的選項,啟用之後轉出的PDF檔,除了可以降低檔案大小之外,還可以加快檔案開啟的速度。

修定日期:2014年10月21日

八、

顏色校對

因為不同的電腦螢幕多多少少都有色差問題,所以很難確保Reviewer能夠看到圖片或圖譜的「真實色彩」。對此,FDA建議圖片或圖譜使用的校色標準為「CMYK模式」,以確保文件輸出時的色彩得以一致。

如需使用色彩管理的設定,請使用 PDFCreator 或是 Adobe Acrobat輸出PDF檔案。

PDFCreator 的設定如下圖:

修定日期:2014年10月21日

Adobe Acrobat 則在印表機設定裡:

修定日期:2014年10月21日

九、 行銷材料、手冊 (Promotional Material)

行銷所使用的檔案文件,請使用原尺吋掃瞄,解析度請設定為600 dpi。如果必須裁切尺吋,則請務必標註實際尺吋大小。圖片掃瞄亦請使用600 dpi 解析度設定。立體的材料則請秀出各個面向及所有的組成元件。 十、

附件:FDA PORTABLE DOCUMENT FORMAT (PDF) SPECIFICATIONS 3.1

FDA PORTABLE DOCUMENT FORMAT (PDF) SPECIFICATIONS

Revision History Date 2005-04-08 2008-06-04 2011-12-20 Summary of Changes Initial version Changed “Bookmarks and Page” to “Bookmarks Panel and Page” in Open Dialog Box section Updated to align with ICH recommendation on PDF version 1.7; add “Purpose” section; clarify specifications related to security, usability, and promotional materials; revise list of standard fonts; add PDF optimization; and incorporate editorial changes Clarified language on acceptable PDF versions for documents; added page numbers Version 1.0 2.0 3.0 2012-1-20 3.1 FDA PORTABLE DOCUMENT FORMAT (PDF) SPECIFICATIONS

PURPOSE

These specifications are for submitting documents in Portable Document Format (PDF). The purpose of this document is to provide specifications for submitting PDF files that align with the ICH M2 recommendations1 and that are in a format that the receiving Center currently supports. For purposes of this document, “supports” means the receiving Center has established processes and technology infrastructure to support the receipt, processing, review, and archive of files in the specified standard format. PDF is an open, published format created by Adobe Systems Incorporated (http://www.adobe.com). Software from a variety of sources can be used to create files in the PDF format.

1

ICH has adopted the use of ISO 32000-1 without extensions and with the

following restrictions - PDF files must not contain: JavaScript; dynamic content which can include audio, video or special effects and animations; attachments; or 3D content. See http://estri.ich.org/recommendations/PDF V2 0.pdf

修定日期:2014年10月21日

VERSION

PDF versions 1.4 through 1.7 are acceptable. Submitted PDF files should be

readable by Adobe Acrobat 8.0, should not require additional software or plug-ins to be read and navigated, and should be text searchable. If plug-ins are used

during the creation of a PDF document, prior to submitting the document, ensure that a plug-in is not needed for review or archive.

SECURITY

Do not activate security settings or password protection. The integrity of the submitted files is maintained through Agency security and archival processes. A copy of the files, generated from the submitted files, will be provided to the

reviewer. The reviewer should be able to print, select text and graphics, and make changes to text, notes and form fields using the provided copy.

FDA Forms downloaded from the FDA Forms website contain security settings that prevent changing the documents. These forms should be submitted as provided, with no additional security added and without removing the provided security settings.

FONTS

Embed all fonts. PDF viewing software automatically substitutes a font to display text if the font used to create the text is unavailable on the reviewer’s computer. In some cases, font substitution can occur even when the fonts are available. For example, Helvetica or Times are substituted even if available on the reviewer’s computer. Font substitution can affect a document’s appearance and structure, and in some cases it can affect the information conveyed by a document. Font availability to the reviewer is ensured if all fonts are embedded. When fonts are embedded, all characters for the font should be included not just a subset of the fonts being used in the document. Inspect documents to make sure all fonts are fully embedded prior to submission.

Font embedding does not always solve the problems that occur when a reviewer tries to copy and paste text from a PDF document into another software format. If the font is not available on the reviewer’s computer, font substitution results, even if the fonts are embedded. This problem is avoided if the fonts are restricted to those listed in Table 1.

Font name Arial Arial Italic Arial Bold Arial Bold Italic Courier New Courier New Italic Courier New Bold Courier New Bold Italic Times New Roman Times New Roman Italic Times New Roman Bold Times New Roman Bold Italic Symbol Zapf Dingbats Table 1: List of Standard Fonts Font type Sans Serif Non Proportional Serif Other

修定日期:2014年10月21日


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