The number of pages within the document is: 10
The self-declared author(s) is/are:
Gary M Gensinger
The subject is as follows:
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The original URL is: LINK
The access date was:
2019-02-13 13:39:13.409160
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PURPOSE These specifications are for creating documents in Portable Document Format (PDF) for submission to CDER or CBER, that align with 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 (www.adobe.com). Software from a variety of sources can be used to create files in the PDF format. VERSION PDF versions 1.4 through 1.7, PDF/A-1 and PDF/A-2 are acceptable for documents. Submitted PDF files should be readable by Adobe Acrobat X, should not require additional software or plugins 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. PDF files must not contain JavaScript; dynamic content which can include audio, video or special effects and animations; attachments or 3D content.2 Do not include PDF annotations in documents.3 Ensure that all hypertext links in documents remain active after conversion to PDF/A. 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. etc.
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