Notice 1/30/2019
FDA Extends Compliance Date for Submitting DMF Type lll in eCTD format
FDA Extends Compliance Date for Submitting DMF Type lll in eCTD format
The FDA extended the compliance date for submitting DMF Type lll in eCTD format to May 5, 2020. See the FDA guidance document for additional information on the compliance date and FDA’s Drug Master File page for additional information on DMFs.
The utility Windows Key+X menu editor takes care of that problem. Source: Three Ways to Easily Access Your Most Recent Documents and Files in Windows 8.x Gizmo’s Freeware Note: The original article was for Windows 8.1, but this works on Windows 10 at the time of writing this. Have something to add to the explanation? Sound off in the comments. Hello and welcome to CarConfections! In this Tech Help episode we will be taking a look at the newest version (2016) of Toyota Entune system, that is seen in.
Notice 11/30/2018
- This screen enables you to create a new blank document or a document from a template. And when you exit a document and return later, Word 2016 resumes where you left off. Starting Word In this exercise, you learn how to start Word using Windows 10. In Windows 10, clicking the Start button displays the Start menu (see Figure 1-2).
- On the Mac, selecting the File menu and then Open (or just pressing Command + O) gets you to the File Open dialog box. Note: On Office 2016 for Mac you may need to click the Online Locations button to get to this dialog.
FDA plans to accept eCTD sequences with an eCTD submission type of “REMS Supplement” in the future. Implementation date is TBD. See submission-type.xml and M1 Specifications (located in the eCTD Submission Standards) for details.
Notice 6/1/2018
Please be advised that the FDA’s eCTD Access Data Website will update ciphers and SSL protocols in Production on September 1, 2018.
Please be advised that the FDA’s eCTD Access Data Website will update ciphers and SSL protocols in Production on September 1, 2018.
Please make sure your system used to connect with the FDA’s eCTD Access Data website can connect with compatible secure ciphers and SSL protocols listed below.
SSL Protocols / Cipher Suites
TLS 1.1 or higher
SSL Protocols / Cipher Suites
TLS 1.1 or higher
Example links to eCTD Access Data Website:
http://www.accessdata.fda.gov/static/eCTD/us-regional-v3-3.dtd
http://www.accessdata.fda.gov/static/eCTD/us-regional.xsl
http://www.accessdata.fda.gov/static/eCTD/us-regional-v3-3.dtd
http://www.accessdata.fda.gov/static/eCTD/us-regional.xsl
What action do you need to take?
If you want to continue to access the eCTD Access Data website, you need to ensure your browser(s)/Servers have TLS 1.1 or higher enabled. If your browser or Servers do not have TLS 1.1 or higher enabled after FDA makes this change, then you will NOT be able to access these eCTD websites.
If you want to continue to access the eCTD Access Data website, you need to ensure your browser(s)/Servers have TLS 1.1 or higher enabled. If your browser or Servers do not have TLS 1.1 or higher enabled after FDA makes this change, then you will NOT be able to access these eCTD websites.
Backend servers that communicate with the eCTD Access Data Website links should also be communicating using TLS 1.1 or higher. Please contact your IT System Administrators or Technology Support personnel for appropriate methods to enable/upgrade your servers.
Notice 4/24/2018
FDA Extends Compliance Date for Submitting DMF Type lll in eCTD Format
FDA Extends Compliance Date for Submitting DMF Type lll in eCTD Format
The FDA extended the compliance date for submitting DMF Type lll in eCTD format to May 5, 2019. See the FDA guidance document for additional information on the compliance date and FDA’s Drug Master File page for additional information on DMFs (4/24/2018)
Important Note 4/7/2017
FDA Extends compliance date for submitting DMFs in eCTD format
FDA Extends compliance date for submitting DMFs in eCTD format
New File Menu 1 4 2016 Download
The FDA extended the compliance for submitting DMF’s in eCTD format to May 5, 2018. See the FDA eCTD guidance document for additional information
Important Note 5/18/2016
Third Acknowledgement for Successful eCTD Submissions
Third Acknowledgement for Successful eCTD Submissions
Beginning May 31, 2016, CDER will begin issuing an acknowledgement to FDA Electronic Submissions Gateway (ESG) users when their NDA, ANDA, BLA, IND or DMF submission has successfully completed validation and processing, and is available to the assigned review division. This acknowledgement is in addition to the ESG Message Delivery Notification acknowledgement (first acknowledgement) and the Official Center acknowledgement (second acknowledgement), and is referred to as the 'third acknowledgement'.
Important Note 02/2014:
FDA has published revised final versions of the following four documents that support making regulatory submissions in electronic format using the electronic Common Technical Document (eCTD) specifications: 'The eCTD Backbone Files Specification for Module 1,' version 2.3 (which includes the U.S. regional document type definition (DTD), version 3.3); ' The Comprehensive Table of Contents Headings and Hierarchy,' version 2.3; 'Specifications for eCTD Validation Criteria,' version 3.1; and 'Example Submissions using eCTD Backbone Files Specification for Module 1,' version 1.3. Technical files that support these documents are also available. Please see the eCTD Data Standards.
Important Note 07/2013:
Update 10/05/2015: Removed option for mailing. Submissions are to be made electronically.
Submission of periodic safety reports to the eCTD
Periodic safety reports consist of two parts: a descriptive portion and the individual case safety reports (ICSRs). Only the descriptive portion of the periodic safety report can be submitted to the eCTD.
Descriptive portion:
Firms can submit the descriptive portion of the periodic safety report in the following formats: the periodic adverse drug experience report, the periodic adverse experience report or, with an approved waiver, either the periodic safety update report or the periodic benefit-risk evaluation report. The descriptive portion can be submitted to the eCTD in module 5.3.6 and should indicate that the ICSRs have been submitted electronically as XML files to the FDA Electronic Submissions Gateway (ESG).
ICSRs:
Firms can submit ICSRs electronically using ICH E2B(R) standards via the FDA Electronic Submission Gateway (ESG) or via the Safety Reporting Portal (SRP). Submission of ICSRs to the eCTD is not acceptable because these ICSRs cannot be processed into the FDA Adverse Event Reporting System (FAERS) database.
Important Note 04/2013:
FDA has published a new document, 'Specifications for File Format Types Using eCTD Specifications.' Please note that file types specified in this document as acceptable in eCTD subsections within 1.15 Promotional material may not be submitted using the current Module 1 (US Regional DTD v. 2.01), as these subsections do not exist in that version. The file types specified for 1.15 subsections are intended for use in the updated Module 1 (US Regional DTD v. 3.1 or higher), once it is implemented.
Important Note 02/2013:
FDA has completed testing and will deploy upgrades to its validation software in April 2013. The Specifications for eCTD Validation Criteria, Version 2.1 will be in effect no later than April 30, 2013. The updated validation software will allow support for Valid Values v. 3.0, which has been posted to the eCTD website under 'eCTD Supportive Files'.
- eCTD Validation Criteria
Important Note 04/2012:
CDER's Office of Prescription Drug Promotion (formerly Division of Drug Marketing, Advertising and Communications - DDMAC) does not accept submissions in eCTD format or via the Electronic Secure Gateway at this time. If received, these submissions will be rejected by CDER. For information about submissions to OPDP, please refer to the following web page: http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm090142.htm
1. Basic Navigation | |
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Ctrl+1 | Switch to Mail |
Ctrl+2 | Switch to Calendar |
Ctrl+3 | Switch to Contacts |
Ctrl+4 | Switch to Tasks |
Ctrl+5 | Switch to Notes |
Ctrl+6 | Switch to Folder List in Navigation Pane |
Ctrl+7 | Switch to Shortcuts |
Ctrl+Period / Ctrl+Comma | Switch to next/previous message (with message open) |
Ctrl+Shift+Tab or Shift+Tab | Move between the Folder Pane, main Outlook window, Reading Pane, and To-Do Bar |
Tab | Move between the Outlook window, the smaller panes in the Folder Pane, the Reading Pane, and the sections in the To-Do Bar |
F6 | Move between the Outlook window, the smaller panes in the Folder Pane, the Reading Pane, and the sections in the To-Do Bar, and the menu access keys in the Outlook ribbon |
Ctrl+Tab | Move around message header lines in the Folder Pane or an open message |
Arrow Keys | Move around within the Folder Pane |
Ctrl+Y | Go to a different folder |
Ctrl+E or F3 | Go to the Search box |
Alt+Arrow Up or Ctrl+, or Alt+Page Up | In the Reading Pane, go to the previous message |
Space / Shift+Space | In the Reading Pane, page down/up through text |
Arrow LeftArrow Right | Collapse or expand a group in the email message list, respectively |
Alt+B or Alt+Arrow Left | Go back to previous view in main Outlook window |
Alt+Arrow Right | Go forward to next view in main Outlook window |
Ctrl+Shift+W | Select the InfoBar and, if available, show the menu of commands |
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2. Search | |
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Ctrl+E | Find a message or other item |
Esc | Clear the search results |
Ctrl+Alt+A | Expand the search to include All Mail Items, All Calendar Items, or All Contact Items, depending on the selected Outlook function |
Ctrl+Shift+F | Use Advanced Find |
Ctrl+Shift+P | Create a Search Folder |
F4 | Search for text within an open item |
Ctrl+H | Find and replace text, symbols, or some formatting commands. Works in the Reading Pane on an open item |
Ctrl+Alt+K | Expand search to include items from the current folder |
Ctrl+Alt+Z | Expand search to include subfolders |
New File Menu 1 4 2016 Download
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3. Common Commands: Common To Most Views | |
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Ctrl+S or Shift+F12 | Save (except in Tasks) |
Alt+S | Save and close (except in Mail) |
F12 | Save as (only in Mail) |
Ctrl+Z or Alt+Backspace | Undo |
Ctrl+D | Delete an item |
Ctrl+P | |
Ctrl+Shift+Y | Copy an item |
Ctrl+Shift+V | Move an item |
Ctrl+K | Check names |
F7 | Check spelling |
Ctrl+Shift+G | Flag for follow-up |
Ctrl+F | Forward |
Alt+S | Send or post or invite all |
F2 | Enable editing in a field (except in Mail or Icon view) |
Ctrl+L | Left align text |
Ctrl+E | Center text |
Ctrl+R | Right align text |
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4. Common Commands: Format Text and work with Editor | |
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Ctrl+X or Shift+Delete | Cut (selected text) |
Ctrl+C or Ctrl+Insert | Copy (selected text), NOTE: Ctrl+Insert is not available in the Reading Pane |
Ctrl+V or Shift+Insert | Paste (from clipboard) |
Ctrl+B | Bold |
Ctrl+U | Underline |
Ctrl+I | Italics |
Ctrl+] or Ctrl+Shift+> | Increase font size |
Ctrl+[ or Ctrl+Shift+< | Decrease font size |
Shift+F3 | Switch case (selected text) |
Ctrl+Shift+K | Format letters as small capitals |
Alt+O | Display the Format menu |
Ctrl+Shift+P | Display the Font dialog box |
Ctrl+Shift+L | Add bullets |
Ctrl+T / Ctrl+Shift+T | Increase Decrease indent |
Ctrl+L | Left align |
Ctrl+E | Center |
Ctrl+Shift+Z or Ctrl+Space | Clear formatting |
Ctrl+Shift+H | Delete the next word |
Ctrl+Shift+J | Stretch a paragraph to fit between the margins |
Ctrl+Shift+S | Apply styles |
Ctrl+T / Ctrl+Shift+T | Create/reduce a hanging indent |
Ctrl+K | Insert a hyperlink |
Ctrl+L / Ctrl+R | Left/Right align a paragraph |
Ctrl+Q | Remove paragraph formatting |
Ctrl+Shift+8 | Toggle show/hide formatting marks. Must be in email body for this to work. |
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5. Common Commands: Add Links and Edit URLs | |
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Ctrl+Left Mouse Click | Edit a URL in the body of an item |
Ctrl+K | Insert hyperlink |
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6. Common Commands: Create Item or File | |
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Ctrl+Shift+A | Create an appointment |
Ctrl+Shift+C | Create a contact |
Ctrl+Shift+L | Create a contact group |
Ctrl+Shift+X | Create a fax |
Ctrl+Shift+E | Create a folder |
Ctrl+Shift+Q | Create a meeting request |
Ctrl+Shift+M | Create a message |
Ctrl+Shift+N | Create a note |
Ctrl+Shift+H | Create a Microsoft Office document |
Ctrl+Shift+S | Post to this folder |
Ctrl+T | Post a reply in this folder |
Ctrl+Shift+P | Create a Search Folder |
Ctrl+Shift+K | Create a task |
Ctrl+Shift+U | Create a task request |
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7. Common Commands: Color Categories | |
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Alt+D | Delete the selected category from the list in the Color Categories dialog box |
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8. Common Commands: Flags | |
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Ctrl+Shift+G | Open the Flag for Follow Up dialog box to assign a flag |
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9. Mail | |
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Ctrl+Shift+I | Switch to Inbox |
Ctrl+O | Pop Out email reply in new window |
Ctrl+Shift+O | Switch to Outbox |
Alt+M | Choose the account from which to send a message |
Ctrl+K | Check names |
Alt+S | Send |
Ctrl+R | Reply to a message |
Ctrl+Shift+R | Reply all to a message |
Ctrl+Alt+R | Reply with meeting request |
Ctrl+F | Forward a message |
Ctrl+Alt+J | Mark a message as not junk |
Ctrl+Shift+I | Display blocked external content (in a message) |
Ctrl+Shift+S | Post to a folder |
Ctrl+Shift+N | Apply Normal style |
Ctrl+M or F9 | Check for new messages |
Arrow Up | Go to the previous message |
Arrow Down | Go to the next message |
Ctrl+N | Create a message (when in Mail) |
Ctrl+Shift+M | Create a message (from any Outlook view) |
Ctrl+O | Open a received message |
Ctrl+Shift+D | Delete and Ignore a Conversation |
Ctrl+Shift+B | Open the Address Book |
Insert | Add a Quick Flag to an unopened message |
Ctrl+Shift+G | Display the Flag for Follow Up dialog box |
Ctrl+Q / Ctrl+U | Mark as read/unread |
Ctrl+Shift+W | Open the Mail Tip in the selected message |
F4 | Find or replace |
Shift+F4 | Find next |
Ctrl+Enter | Send |
Ctrl+P | |
Ctrl+F | Forward |
Ctrl+Alt+F | Forward as attachment |
Alt+Enter | Show the properties for the selected item |
Ctrl+Shift+U | Create a multimedia message |
Ctrl+Alt+M | Mark for Download |
Ctrl+Alt+U | Clear Mark for Download |
Ctrl+B | Display Send/Receive progress |
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10. Calendar | |
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Ctrl+N | Create an appointment (when in Calendar) |
Ctrl+Shift+A | Create an appointment (in any Outlook view) |
Ctrl+Shift+Q | Create a meeting request |
Ctrl+F | Forward an appointment or meeting |
Ctrl+R | Reply to a meeting request with a message |
Ctrl+Shift+R | Reply All to a meeting request with a message |
Alt+1 | Show 1 day in the calendar |
Alt+2 | Show 2 days in the calendar |
Alt+3 | Show 3 days in the calendar |
Alt+3 | Show 4 days in the calendar |
Alt+5 | Show 5 days in the calendar |
Alt+6 | Show 6 days in the calendar |
Alt+7 | Show 7 days in the calendar |
Alt+8 | Show 8days in the calendar |
Alt+9 | Show 9 days in the calendar |
Alt+0 | Show 10 days in the calendar |
Ctrl+G | Go to a date |
Alt+= or Ctrl+Alt+4 | Switch to Month view |
Ctrl+Arrow Right / Ctrl+Arrow Left | Go to the next/previous day |
Alt+Arrow Down / Alt+Arrow Up | Go to the next/previous week |
Alt+Page Down / Alt+Page Up | Go to the next/previous month |
Alt+Home / Alt+End | Go to the start/end of the week |
Alt+- or Ctrl+Alt+3 | Switch to Full Week view |
Ctrl+Alt+2 | Switch to Work Week view |
Ctrl+, or Ctrl+Shift+, / Ctrl+. or Ctrl+Shift+. | Go to previous/next appointment |
Ctrl+G | Set up recurrence for an open appointment or meeting |
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11. People | |
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Ctrl+Shift+D | Dial a new call |
F3 or Ctrl+E | Find a contact or other item (Search) |
F11 | Enter a name in the Search Address Books box |
Shift+letter | In Table or List view of contacts, go to first contact that starts with a specific letter |
Ctrl+A | Select all contacts |
Ctrl+F | Create a message with selected contact as subject |
Ctrl+N | Create a contact (when in Contacts) |
Ctrl+Shift+C | Create a contact (from any Outlook view) |
Ctrl+O | Open a contact form for the selected contact |
Ctrl+Shift+L | Create a contact group |
Ctrl+P | |
F5 | Update a list of contact group members |
Ctrl+Y | Go to a different folder |
Ctrl+Shift+B | Open the Address Book |
Ctrl+Shift+F | Use Advanced Find |
Ctrl+Shift+. | In an open contact, open the next contact listed |
F11 | Find a contact |
Esc | Close a contact |
Ctrl+Shift+X | Send a fax to the selected contact |
Alt+D | Open the Check Address dialog box |
Alt+Shift+1 | In a contact form, under Internet, display the Email 1 information |
Alt+Shift+2 | In a contact form, under Internet, display the Email 2 information |
Alt+Shift+3 | In a contact form, under Internet, display the Email 3 information |
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12. People: Electronic Business Cards | |
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Alt+A | Open the Add list |
Alt+B | Select text in Label box when the field with a label assigned is selected |
Alt+C | Open the Add Card Picture dialog box |
Alt+E | Place cursor at beginning of Edit box |
Alt+F | Select the Fields box |
Alt+G | Select the Image Align drop-down list |
Alt+K, then Enter | Select color palette for background |
Alt+L | Select Layout drop-down list |
Alt+R | Remove a selected field from the Fields box |
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13. Tasks | |
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Alt+C | Accept a task request |
Ctrl+D | Decline a task request |
Ctrl+E | Find a task or other item |
Ctrl+Y | Open the Go to Folder dialog box |
Ctrl+N | Create a task (when in Tasks) |
Ctrl+Shift+K | Create a task (from any Outlook view) |
Ctrl+O | Open selected item |
Ctrl+P | Print selected item |
Ctrl+A | Select all items |
Ctrl+D | Delete selected item |
Ctrl+F | Forward a task as an attachment |
Ctrl+Shift+Ctrl+U | Create a task request |
Tab or Shift+Tab | Switch between the Folder Pane, Tasks list, and To-Do Bar |
Ctrl+Z | Undo last action |
Insert | Flag an item or mark complete |
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14. Groups | |
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Arrow Right / Arrow Left | Expand/collapse a single selected group |
Arrow Up / Arrow Down | Select the previous/next group |
Home / End | Select the first/last group |
Arrow Right | Select the first item on screen in an expanded group or the first item off screen to the right |
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15. Print | |
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Alt+F, then P | Open Print tab in Backstage view |
Alt+F, then F, then 1 | To print an item from an open window |
Alt+S, or Alt+U | Open Page Setup from Print Preview |
Alt+F, then P, then I | To select a printer from Print Preview |
Alt+F, then P, then L | To Define Print Styles |
Alt+F, then P, then R | To open Print Options |
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16. Send/Receive | |
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F9 | Start a send/receive for all defined Send/Receive groups with Include this group in Send/Receive (F9) selected. This can include headers, full items, specified folders, items less than a specific size, or any combination that you define |
Shift+F9 | Start a send/receive for the current folder, retrieving full items (header, item, and any attachments) |
Ctrl+M | Start a send/receive |
Ctrl+Alt+S | Define Send/Receive groups |
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New File Menu 1 4 2016 Full
17. Macros | |
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Alt+F8 | Play Macro |
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18. Views: Table View | |
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Enter | Open an item |
Ctrl+A | Select all items |
Page Down / Page Up | Go to the item at the bottom/top of the screen |
Shift+Arrow Up or Shift+Arrow Down | Extend or reduce the selected items by one item |
Ctrl+Arrow Up or Ctrl+Arrow Down | Go to the next or previous item without extending the selection |
Ctrl+Space | Select or cancel selection of the active item |
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19. View: Business Cards/Address cards | |
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a-z | Select a specific card in the list (type one or more letters of the name that the card) |
Arrow Up / Arrow Down | Select the previous/next card |
Home / End | Select the first/last card in the list |
Page Up / Page Down | Select the first card on the current/next page |
Arrow Right / Arrow Left | Select the closest card in the next/previous column |
Ctrl+Space | Select or cancel selection of the active card |
Shift+Arrow Up | Extend the selection to the previous card and cancel selection of cards after the starting point |
Shift+Arrow Down | Extend the selection to the next card and cancel selection of cards before the starting point |
Ctrl+Shift+Arrow Up | Extend the selection to the previous card, regardless of the starting point |
Ctrl+Shift+Arrow Down | Extend the selection to the next card, regardless of the starting point. |
Shift+Home / Shift+End | Extend the selection to the first/last card in the list |
Shift+Page Up / Shift+Page Down | Extend the selection to the first/last card on the previous page |
Tab / Shift+Tab | Move to the next/previous field and control (in an open card) |
Enter | Close the active card (in an open card) |
Enter | Add a line in a multiline field (when a field in a card is selected) |
Home / End | Move to the beginning/end of a line (when a field in a card is selected) |
Page Up / Page Down | Move to the beginning/end of a multiline field (when a field in a card is selected) |
Arrow Up / Arrow Down | Move to the previous/next line in a multiline field (when a field in a card is selected) |
Arrow Left / Arrow Right | Move to the previous/next character in a field (when a field in a card is selected) |
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20. View: Timeline (Tasks) - When an item is selected | |
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Arrow Left / Arrow Right | Select the previous/next item |
Shift+Arrow Left or Shift+Arrow Right | Select several adjacent items |
Ctrl+Arrow Left+Space or Ctrl+Arrow Right+Space | Select several nonadjacent items |
Enter | Open the selected items |
Home / End | Select the first/last item on the timeline (if items are not grouped) or the first item in the group |
Ctrl+Home / Ctrl+End | Display (without selecting) the first/last item on the timeline (if items are not grouped) or the first item in the group |
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21. View: Timeline (Tasks) - When a group is selected | |
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Enter or Arrow Right | Expand the group |
Enter or Arrow Left | Collapse the group |
Arrow UpArrow Down | Select the previous/next group |
Home / End | Select the first/last group on the timeline |
Arrow Right | Select the first item on screen in an expanded group or the first item off screen to the right |
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![New file menu 1 4 2016 full New file menu 1 4 2016 full](https://www.addintools.com/documents/office/images/where-file-properties/word-file-properties-menus-345-466.png)
22. View: Timeline (Tasks) - When a unit of time for days is selected | |
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ArrowLeft / Arrow Right | Move backward/forward in increments of time that are the same as those shown on the time scale |
Tab and Shift+Tab | Switch between active view, To-Do Bar, Search and back to active view |
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23. View: Calendar - Day/Week/Month | |
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Alt+key for number of days | View from 1 through 9 days |
Alt+0 | View 10 days |
Alt+- | Switch to weeks |
Alt+= | Switch to months |
Ctrl+Tab or F6 | Move between Calendar, TaskPad, and the Folder List |
Shift+Tab | Select the previous appointment |
Arrow Left / Arrow Right | Go to the previous/next day |
Alt+Arrow Down / Alt+Arrow Up | Go to the same day in the next/previous week |
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24. View: Calendar - Day View | |
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Home | Select the time that begins your work day |
End | Select the time that ends your work day |
Arrow Up / Arrow Down | Select the previous/next block of time |
Page Up / Page Down | Select the block of time at the top/bottom of the screen |
Shift+Arrow Up or Shift+Arrow Down | Extend or reduce the selected time |
Alt+Arrow Up or Alt+Arrow Down | Move an appointment up or down |
Alt+Shift+Arrow Up or Alt+Shift+Arrow Down | Change an appointment's start or end time |
Alt+Arrow Down | Move selected item to the same day in the next week |
Alt+Arrow Up or Alt+Arrow Down | Move selected item to the same day in the previous week |
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25. View: Calendar - Week View | |
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Home / End | Go to the start/end of work hours for the selected day |
Page Up / Page Down | Go up/down one page view in the selected day |
Shift+Arrow Left, Shift+Arrow Right, Shift+Arrow Up, Shift+Arrow Down or Shift+Home or Shift+End | Change the duration of the selected block of time |
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26. View: Calendar - Month View | |
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Home | Go to the first day of the week |
Page Up / Page Down | Go to the same day of the week in the previous/next page |
▲ up
27. Date Navigator | |
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Alt+Home / Alt+End | Go to the first/last day of the current week |
Alt+Arrow Up / Alt+Arrow Down | Go to the same day in the previous/next week |