Portable Document Files

Many publishers now accept properly created Portable Document Files, or PDFs. A PDF document is created when an application file produced by any of a number of software programs is distilled , using software such as Adobe s Acrobat Distiller. The PDF document can be viewed on any platform using viewing software such as Adobe s Acrobat Reader, regardless of whether the viewer has the original application software. 

Documents should be provided, where possible, as individual Portable Document Format (PDF) files, while Extensible Markup Language (XML) must be used to provide a user interface that enables navigation and viewing via a standard web browser. This offers the potential for an applicant to make a compete submission on... 

This guidance document governs how electronic files should be sent to the FDA. Currently, the FDA requests that electronic documents be submitted as Portable Document Format (PDF) files. The PDF page should be a standard 8.5" x 11" page with 1" margins and 12-point font. Data sets are currently to be sent to the FDA as SAS XPORT transport format files. In the future it is likely that data sets will be required to be sent as XMF files, probably formatted in the CDISC ODM. 

PDF stands for Portable Document Format, which is an open document description language created by Adobe Systems Inc. PDF files have several advantages over RTF and ASCII text files ... 

File format All files should be submitted in portable document format (PDF). The version of Acrobat Reader to be used for review should be confirmed with the agency. Electronic data sets should be provided in SAS System XPORT transport format (version 5 SAS transport file). 

Send a 7.5 GB test submission that is representative of an actual submission. The Web Interface archives and compresses the submission into a single file prior to transmission. Submissions that consist of text files will compress to a greater extent than portable document format (PDF) files, will transmit faster, and thus give an inaccurate assessment of the time it takes for submissions to be sent and processed by the FDA ESG. 

To submit electronically a request for a meeting or teleconference, the sponsor should use the Request for a Meeting or Teleconference form provided by the CVM (Form FDA 34895 OMB No. 0910-0452). The sponsor should enter the data directly into an Adobe Acrobat form, attach the Agenda for the meeting, and submit the form to CVM as an Adobe portable document format (PDF) file (compatible with Adobe Acrobat 6.0).6 The electronic submission of a request for meeting or teleconference is part of the Center s ongoing initiative to provide a method for paperless submissions. 

Your submission should include individual portable document format (PDF) files that contain numeric prefixes. The numeric prefix should reflect the amendment number in which the file was submitted for review.The numeric prefix will facilitate the loading of new files into a preexisting folder structure that features the IND main folder and its six subfolders (see Folders ). However, the following PDF files should not contain numeric prefixes roadmap.pdf (see Appendix A), protocolctoapdf [see Protocol and Protocol Revisions (Amendments) and Appendix B, Figure VI-4], and adverse event-stoc.pdf (sec Adverse Events and Appendix B, Figure VI-5). These files are cumulative and will be replaced in subsequent submissions. 

Because the vast majority of published articles are available for download in PDF (portable document format) file format, the ability to feed PDF files into a... 

Continuing readability of documents through technological changes, e.g., the use of Portable Document Format (PDF) file type... 

Users with appropriate system privileges must be able to view documents. Typically, documents to be viewed in an EDMS are presented as read-only files, either in the authoring application or a standard immutable file format such as TIFF (Tagged Image File Format) or Adobe s portable document format (PDF). By virtue of its flexibility and platform-independence, PDF has become the storage standard in contemporary electronic document management systems. Most systems will automatically create PDF files and provide the PDF rendition in response to a user view request. 

In some cases, lists of flavoring materials approved for use in individual countries or economic regions have been placed in the public domain and are readily accessible online and/or are available for download. An example is the EU s so-called EC Flavor Register, a list of more than 2500 flavoring substances which can be used in food [10]. The EU flavoring database includes name, CAS registry number, and various other numeric identifiers, plus purity criteria. It is available online [11] though it can also be downloaded as a searchable portable document format PDF file... 

In the digital age, ideas and information will be reprocessed and reused. Their portability and, consequently, their usefulness are dependent on the ability to find their particular data bit streams within a vast universe of binary number sequences. As the mass of documents in an enterprise EDMS grows and the filing structure that accommodates it both broadens and deepens, retrieving any specific item from the repository becomes more difficult. Speedy and accurate search and retrieval are achieved by allowing searches based on document content, attributes, or both. Users must also be able to save their queries for future reuse and store their queries in a centrally administered, single location. A simple FIND function must allow users to search either all versions of files or to restrict a search to only current versions of files. The system must validate and maintain a controlled list of category values and a controlled list of status values. 

In today s paperless operation, it may be necessary to keep two versions of each document—one in the portable file format (which cannot be edited) and one in the native format of the creating program (which can be edited). Future technologies may change this as the issues become important in more and more areas of society and as such technologies as Hyper Text Markup... 

---