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U.S. Department of Health and Human Services

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Application History

Provided below is a listing of recent updates to the application software in reverse chronological order by version number. For updates prior to this list, consult the Application History Archive.

Version 1.88.02 - Released October 10, 2012
Enhancements
  • None.
Fixes
  • CDER: Fixed the issue to correctly output the Labeler Code in the Labeler Code Request SPL submission.
  • CDER: Fixed the issue to correctly output the Designated U.S. Agent in the Drug Establishment Registration SPL submission.
Version 1.88.01 - Released October 5, 2012
Enhancements
  • Updated product code, guidance, and standards lookup tables.
Fixes
  • Minor updates to the GDUFA Generic Facility Self-Identification template to address a character length issue for Registrant Name and corrected County Codes.
Version 1.87.01 - Released September 17, 2012
Enhancements
  • Released CDRH: Electronic Copy (eCopy) submission type.
  • Updated product code, guidance, and standards lookup tables.
Fixes
  • CDER: Fixed an issue with the NDC Listing submission type where information from the Content of Labeling Information node to Outer Package node were missing from the generated output.
  • CDER: Fixed an issue with the NDC Listing submission type, under Marketing Information where the Application Number or Monograph Citation was required/not required based on the Marketing Category selected that was causing data to be missing from the generated output.
Version 1.86.01 - Released September 5, 2012
Enhancements
  • Released CBER/CDER Generic Drug Facility Electronic Self-Identification submission type.
  • Updated product code, guidance, and standards lookup tables.
Fixes
  • None.
Version 1.85.01 - Released August 6, 2012
Enhancements
  • Released CBER's templates for ICSR Pilot Testing to eSubmitter CBER instance.
  • Updated product code, guidance, and standards lookup tables.
Fixes
  • CDRH: Updated ISO 13485 template, fixing an issue with the Previous Audit Report questions.
  • CDRH: Updates to tabular nodes in Technical Data tab for Laser product reports and minor updates to questions in master template.
  • Fixed an issue where older submissions based on expired templates were not properly converting to the latest template during a "Save-As" process.
Version 1.84.01 - Released July 3, 2012
Enhancements
  • None
Fixes
  • CTP: The Tobacco Product Ingredient Listing has been updated to allow for additional values to be enter into the ingredient quantity fields. The validation rules on the ingredient quantity fields have been updated to now allow values between 0.000 - 999.999 (previously 0.001-999.999). A new import spreadsheet template has been provided.
  • CBER: Statement of acceptability regarding use of non-secure FDA email system for submission communication added to Applicant Information screen on Form FDA 356h template.
  • CBER: Cryoprecipitated AHF and Pooled Cryoprecipitated AHF SOP section content updated.
Version 1.83.01 - Released June 5, 2012
Enhancements
  • CVM: On the Chemistry, Manufacturing and Controls template, the Steam-in-Place questions are located in a new section. Minor updates were also made to Sterility questions. Section 5.0, Module 3 is now enabled and disabled appropriately. This template now allows the user to fill in an "Abbreviated" submission. Questions in regards to excipients are now disabled if the product contains no excipients.
  • CVM: On the Effectiveness Protocol (EF) template, in 2.0 Product Description, the Common Animal Name list of values has been updated.
  • CVM: The Chemistry Supplement template now allows users to enter multiple facilities.
  • CVM: The Chemistry Annual Report and Reactivation of Chemistry Report templates now have the user entering Established Name and Proprietary Name.
  • CDER: Reactivated eSubmitter templates for SPL Drug Registration and Listing.
  • CDRH: Updated the Accidental Radiation Occurrence template to include an additional field to capture radiation exposure date range, type of occurrence as well as a field to capture the number of individuals involved in the incident being reported.
  • Updated product code, guidance, and standards lookup tables.
Version 1.82.01 - Released May 7, 2012
Enhancements
  • CVM: On the Chemistry, Manufacturing and Controls template, the Steam-in-Place questions are located in a new section. Minor updates were also made to Sterility questions. Section 5.0, Module 3 is now enabled and disabled appropriately. This template now allows the user to fill in an "Abbreviated" submission. Questions in regards to excipients are now disabled if the product contains no excipients.
  • CVM: On the Effectiveness Protocol (EF) template, in 2.0 Product Description, the Common Animal Name list of values has been updated.
  • CVM: The Chemistry Supplement template now allows users to enter multiple facilities.
  • CVM: The Chemistry Annual Report and Reactivation of Chemistry Report templates now have the user entering Established Name and Proprietary Name.
  • CDER: Reactivated eSubmitter templates for SPL Drug Registration and Listing.
  • CDRH: Updated the Accidental Radiation Occurrence template to include an additional field to capture radiation exposure date range, type of occurrence as well as a field to capture the number of individuals involved in the incident being reported.
  • Updated product code, guidance, and standards lookup tables.
Fixes

  • CVM: On the Environmental Technical Section (NV) template, in 2.0  Product Description, the list of values for Dosage Form Variation for a Solution has been fixed
Version 1.81.01 - Released April 10, 2012
Enhancements
  • Updated product code, guidance, and standards lookup tables.
Fixes
  • Fixed a validation issue regarding the import of numeric responses within tabular screens.
Version 1.80.01 - Released March 6, 2012
Enhancements
  • Updated product code, guidance, and standards lookup tables.
Fixes
  • CBER: Business rules amended to eliminate instances of data being cleared in SOP templates.
  • CBER: HTML question properties updated to display output correctly in Submission Report PDF. Corrected items include fonts, lists, and tables in HTML question outputs.
  • CVM ONADE: CORE Questions has been updated so that users can no longer submit any User Fee Waiver submissions. These templates are no long accessible in eSubmitter.
Version 1.79.01 - Released February 6, 2012
Enhancements
  • CTP: The Tobacco Product Ingredient Listing has been updated to include additional questions that will support a more structured approach to entering ingredient quantity data. This will affect your existing import spreadsheets and a new import template has been provided.
  • CTP: All CTP Submission Types now have the ability to break up large submissions into multiple submission packages. In the event your submission reached the threshold, you will be notified at the time of packaging. Please continue to submit the packages per your usual method (e.g., ESG or CD).
  • Updated product code, guidance, and standards lookup tables.
Fixes
  • None.
Version 1.78.01 - Released January 9, 2012
Enhancements
  • Updated product code, guidance, and standards lookup tables.
Fixes
  • CBER: Minor bug fixes in "SOPs - General (Automated)" template.
Version 1.77.01 - Released December 5, 2011
Enhancements
  • Updated product code, guidance, and standards lookup tables.
Fixes
  • None.
Version 1.76.01 - Released November 4, 2011
Enhancements
  • CBER Electronic Submission Checklist updated to reflect new address for the Office of Regional Operations. This is the address where the sponsor should send their Letter of Non-Repudiation.
  • Updated product code, guidance, and standards lookup tables.
Fixes
  • Fixed conflicting business rules regarding Comparability Protocol questions on Red Blood Cells, Platelets, Plasma, and Fresh Frozen Plasma product screens in Core Questions template.
  • Fixed conflicting business rules in Computer-Assisted Interactive Donor History section in Processes template so that data entered in Web-Based CASI SOP section is not cleared after being entered.
  • Minor content updates and bug fixes.
Version 1.75.01 - Released October 7, 2011
Enhancements
  • Updated product code, guidance, and standards lookup tables.
  • Released CDER’s eSubmitter templates for SPL Drug Registration and Listing.
  • Released CDER’s eSubmitter templates for ICSR Drug Adverse Event Reporting.
  • Added new folder designation under Preferences to differentiate between standard outputs (e.g., submission and missing data report) and the submission package to minimize confusion regarding which files to submit.
Fixes
  • None.
Version 1.74.01 - Released September 7, 2011
Enhancements
  • Updated product code, guidance, and standards lookup tables.
Fixes
  • Revised the CBER Core Question template to fix a contact question report output issue.
  • Revised the hint text of the Type of Submission question in the 356h template.
  • Fixed an issue here international characters were causing loss of data in the contact and address books.
  • Fixed an issue where sometimes Excel data failed to import.
  • Fixed an issue where sometimes child data of a relationship was not properly being deleted when the parent was deleted.
Version 1.73.01 - Released August 5, 2011
Enhancements
  • CBER Templates updated to reflect transition from Pilot program to live production environment:
    • Inactivated the Pilot Source Plasma template (the production BLA/Source Plasma template should be used instead going forward). However, any existing submissions in progress related to the Pilot Source Plasma template will still have until 2/8/2012 to complete their submissions.
    • Added FEI and Registration Number fields to Establishment Details node in 356h template.
    • Minor fixes and updates made in Labeling template.
  • Adjusted business rules for the "Update to a Registration Listing" when an operator's address is being updated and the operator is also the owner.
  • Added a new Tobacco Product's template to provide an ESG Transmittal Submittal Form.
  • Updated product code, guidance, and standards lookup tables.
Fixes
  • Fixed an issue where some data was not populating correctly in the Rad Health Submittal Letters.
  • Fixed an issue where older look up table data (e.g., product code, guidance, and standards) were not being properly deleted after an update.
Version 1.72.02 - Released July 15, 2011
Enhancements
  • Added "CVM Submission #" to the Reactivation of an Original ANADA.
  • Revised hints for NADA Supplements.
  • Modified rules for JINAD and ANADA Meeting Requests to be sent to Review Division 160.
Fixes
  • None.
Version 1.72.01 - Released July 5, 2011
Enhancements
  • Updated product code, guidance, and standards lookup tables.
Fixes
  • None.
Version 1.71.01 - Released June 6, 2011
Enhancements
  • Adjusted the MedWatch packaging screen by removing the option to submit by CD.
  • Updated product code, guidance, and standards lookup tables.
Fixes
  • Fixed an issue where a required email address for a Rad Health related contact was being allowed to be submitted without a value.
  • Fixed an issue where a required telephone number for a Rad Health related establishment was being allowed to be submitted without a value.
  • Fixed an issue where the reporting date range of a Rad Health annual report was missing from the submittal letter.
Version 1.70.01 - Released May 6, 2011
Enhancements
  • Updated product code, guidance, and standards lookup tables.
Fixes
  • Fixed an issue where the memory settings under the File > Preferences were not saved.
  • Fixed an issue where a missing separator at the end of the file locations of the File > Preferences was causing an issue during packaging.
Version 1.69.01 - Released April 5, 2011
Enhancements
  • Adjusted several Rad Health templates to include the following: updated OMB expiration date, list of laser types, office addresses, and the exponent list for laser output levels.
  • Updated product code, guidance, and standards lookup tables.
Fixes
  • Fixed a list refresh issue after data was imported from an Excel spreadsheet into a tabular screen.
Version 1.68.01 - Released March 11, 2011
Enhancements
  • Released templates for CVM's Office of New Animal Drug Evaluation (ONADE) submissions.
  • BLAs for Whole Blood and Blood Components Labeling template: Added the ability to submit a Previously-Approved Label with a BLA product submission. Previously, user was forced to submit all the details and attach labels, even if labels had already been approved by the FDA.
  • Annual Report template: Changed Reporting Period from a single text field to two unique Date fields to allow for validation of dates.
  • Updated product code, guidance, and standards lookup tables.
Fixes
  • Amendment template: Changed HTML Memo fields to Plain Text Memo fields to fix appearance in Submission Report output
Version 1.67.01 - Released February 11, 2011
Enhancements
  • Updated product code, guidance, and standards lookup tables.
Fixes
  • None.
Version 1.66.01 - Released January 10, 2011
Enhancements
  • Updated product code, guidance, and standards lookup tables.
Fixes
  • None.
Version 1.65.02 - Released December 20, 2010
Enhancements
  • Added templates for new CBER Pilot Evaluation Program for Establishments that Collect Whole Blood and Blood Components.
Fixes
  • Reduced the time required to load submission files.
Version 1.65.01 - Released December 7, 2010
Enhancements
  • Updated product code, guidance, and standards lookup tables.
Fixes
  • Fixed a minor textual change to Rad Health templates.
Version 1.64.01 - Released November 5, 2010
Enhancements
  • Updated product code, guidance, and standards lookup tables.
Fixes
  • None.
Version 1.63.01 - Released October 8, 2010
Enhancements
  • Added new templates in support of the Center for Veterinary Medicine (CVM) eSubmitter "Beta-Test" program.
  • Added sorting capabilities to the Open Submission dialog by clicking on the column header.
  • Began replacing the outdated HTML-based help with links to the more comprehensive user manual.
  • Updated product code, guidance, and standards lookup tables.
Fixes
  • Fixed a minor issue related to Rad Health Annual Reports.
Version 1.62.01 - Released September 21, 2010
Enhancements
  • Updated News and Alerts with information regarding adjusted device problem codes used under F10 of the 3500A MedWatch form
  • Updated product code, guidance, and standards lookup tables
Fixes
  • None.
Version 1.61.01 - Released August 5, 2010
Enhancements
  • Updated product code, guidance, and standards lookup tables.
Fixes
  • Fixed an issue resulting in an error when attempting to create a new submission from the Open Submission Dialog.
Version 1.60.01 - Released July 14, 2010
Enhancements
  • Added a memory configuration section to the preferences dialog to allow user adjustment in support of very large data submissions.
  • Updated product code, guidance, and standards lookup tables.
Fixes
  • Minor updates to Rad Health templates.
Version 1.59.01 - Released June 11, 2010
Enhancements
  • Minor updates to Tobacco Templates 904a1 and 905.
  • Modified the FEI number to allow between 7 and 10 digits.
Fixes
  • Fixed the missing data report to correctly handle relationship logic (currently only used within Tobacco's 904 Template).
  • Fixed the report output to correctly handle relationship logic (currently only used within Tobacco's 904 Template).
Version 1.58.01 - Released May 7, 2010
Enhancements
  • Updated CTP's Templates to include the following:
    • Updates to the product list for the Tobacco Establishment Registration and Product Listing submission
    • Updates to the ingredient list for the Listing of Ingredients in Tobacco Products submission
Fixes
  • Fixed the check box in the Tobacco Health Documents Submission report output.
  • Fixed the telephone number field to prevent the PDF from printing with a null value when international numbers are entered along with spaces to accommodate for the field length.
Version 1.57.02 - Released April 19, 2010
Enhancements
  • Released the Health Documents submission type for CTP.
Fixes
  • None.
Version 1.57.01 - Released April 5, 2010
Enhancements
  • Added new filter option that combines all the singular options into one filter so all file types can be accessed at the same time.
  • Added a new Active indicator to the MDR code data so that all codes are available when viewing data but only Active codes are available for selection
  • Changed address for the OIVD submittal letter
Fixes
  • Fixed issue to correctly identify the zip code as missing when the establishment address question is required.
  • Fixed the issue to prevent file Names and Package Names from being saved with a period.
Version 1.56.01 - Released March 5, 2010
Enhancements
  • Updated Tobacco's Templates to include the following:
    • Added a warning message when the user changes the selection of "New Submission" to "Update".
    • Modified question on Submission Content screen.
    • Added the ingredient name as the internal identifier.
    • Included the memo field with the file attachment to allow users to provide additional information when necessary.
  • Updated the contact information for CDRH's Office of In-Vitro Diagnostic Devices.
  • Minor updates to the eMDR's Template.
  • Updated product code, guidance, and standards lookup tables.
Fixes
  • None.
Version 1.55.01 - Released February 5, 2010
Enhancements
  • Updated the Listing of Ingredients for Tobacco Products template to include minor revisions to the FDA-assigned Tobacco Product (TP) Number.
  • Updated the contact information for CDRH's Office of In-Vitro Diagnostic Devices.
  • Updated product code, guidance, and standards lookup tables.
Fixes
  • None.
Version 1.54.01 - Released January 6, 2010
Enhancements
  • Added the file description text entered for file attachment responses to the Submission Report output (PDF version).
  • Updated the OMB expiration date on the 3500A template screen footer.
  • Updated product code, guidance, and standards lookup tables.
Fixes
  • Fixed an issue where text entered in place of attaching a file was not outputting on the Submission Report (PDF version).
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Previous Updates

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