For Industry

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 2.20.02 - Released July 9, 2015
Enhancements
  • None.
Fixes
  • CDRH: Fixed an issue with the patient and device problem code lists.
  • CDRH: Fixed an issue where the "Other Number" response from section D was missing from the output file.
Version 2.20.01 - Released July 8, 2015
Enhancements
  • CDRH: Updated product code, guidance, and standards lookup tables.
Fixes
  • CBER VAERS: Adjusted the language codes to properly reflect the ISO 639-2 data standard.
Version 2.19.04 - Released June 24, 2015
Enhancements
  • CBER VAERS: Adjusted the limit for adding associated persons so that only one parent can be added for VAERS reporting.
  • CBER VAERS: Adjusted the patient drug history section so that one drug history item is required, the name of the drug should be set to "NA" if no drug history information is available.
Fixes
  • Fixed an issue related to the table question losing data when a submission is reopened.
     
Version 2.19.03 - Released June 9, 2015
Enhancements
  • Released CBER Individual Case Safety Reports (ICSR) to Production. 
Fixes
  • Fixed an issue where some users were incorrectly receiving validation errors resulting from valid phone entry.
Version 2.19.02 - Released June 8, 2015
Enhancements
  • None.
Fixes
  • CVM: Fixed an issue in the I/P/NV eSubmitter template preventing sponsors from being able to submit when they are requesting a Categorical Exclusion.
  • CVM: Fixed an issues in the N/B/CA and A/B/CA templates pertaining to missing questions.
Version 2.19.01 - Released June 5, 2015
Enhancements
  • Added support under preferences for identifying where contact/address book information is stored.
  • CDRH: Updated product code, guidance, and standards lookup tables.
Fixes
  • CBER VAERS Pilot: Removed the redundant folder from the output, now the output message will be saved directly to the package folder.
  • CBER VAERS Pilot: Revised the Testing Result data entry section to better support singular and range values.
  • CBER VAERS Pilot: Adjusted UCUM selection lists and numeric representations (integer/decimal), as needed.
  • CBER VAERS Pilot: Added missing codes to the Facility Type list.
  • CBER VAERS Pilot: Removed duplicates from the Language selection list.
  • CBER VAERS Pilot: Refined the validation checks on the MedDRA version number to ensure proper formatting.
  • CBER VAERS Pilot: Adjusted the Vaccination Military Status to support Yes, No, and No Information.
  • CBER VAERS Pilot: Added Code System data entry to Dose Form, Route of Admin, and Parent Route of Admin when entering a term that is not part of the SPL code set.
  • CBER VAERS Pilot: Fixed an issue where the Name of the Drug Provided was not properly outputting NA as a null flavor.
  • CBER VAERS Pilot: Added a hint to MPID Version/Date entry to reflect the proper format of the data to be provided.
Version 2.18.03 - Released May 13, 2015
Enhancements
  • None.
Fixes
  • CVM: Fixed an issue within the generated submission package where the purpose of submission was not set correctly for Z and Y Submission Types (A/Z/OM, A/Y/OM, G/Z/OM, G/Y/OM, I/Z/OM, I/Y/OM, J/Z/OM, J/Y/OM, N/Z/OM, N/Y/OM, V/Z/OM, V/Y/OM).
Version 2.18.02 - Released May 8, 2015
Enhancements
  • None.
Fixes
  • CVM: Fixed an issue with the I/J-P-MC templates that was preventing access to Module 3 information.
  • CDER/CBER GDUFA Generic Facility Self-Identification template: Fixed an issue related to Business Operations and non-generics.
Version 2.18.01 - Released May 5, 2015
Enhancements
  • CTP: Users will no longer have the ability to attach zip files in any of the submissions.
  • CBER: Inactivated the Investigational New Drug (IND) Application, including Antivenin INDs, eCTD Structured template.
  • CDRH: Updated product code, guidance, and standards lookup tables.
Fixes
  • CBER VAERS Pilot: Fixed an issue where the drug application number was incorrectly being output when no user response was provided.
Version 2.17.03 - Released April 29, 2015
Enhancements
  • None.
Fixes
  • CVM: Updated eSubmitter to create a new Submission Classification Code (OM-ONADE Meeting). Removed PS and OO as sub class codes. Added a radio button selection to all the Z templates to allow for the selection of either Pre-submission conference (PS) or ONADE Other (OO) meeting.
  • CVM: Updated the INAD A-0000, INAD - Z, GC-A-0000 and GC-Z Templates to include questions pertaining to the submission of early information.
  • CVM: Added a new team to all the meeting request (Z) templates: Team 4 Canine, Feline and Wildlife (HFV-118).
  • CVM: Updated the (J)INAD templates to change the business rules to collect only one referenced submission.
  • CVM: Updated the (J)INAD B-OT, J/INAD-P-NV, and J/INAD-X templates.
  • CVM: Deactivated the VMF-P-OT Template.
  • CVM: Updated (A)NADA R-CS, AS Templates to add a message instructing sponsors that might be trying to respond to a Prior Approval Supplement incomplete letter as a CBE30.
  • CBER VAERS Pilot: Adjusted available nullflavor responses within Patient/Parent Race and Vaccination Facility Type.
  • CBER VAERS Pilot: Adjusted the Dose number Unit to properly support "{DF}".
  • CBER VAERS Pilot: Fixed an issue where the Primary Source was not outputting the County Code when identified as the Patient.
  • CBER VAERS Pilot: Fixed an issue where the Vaccination Facility Military Status was not properly converting a "No" response to "NI" in the output.
  • CBER VAERS Pilot: Adjusted the OID used when outputting the FDA Specialized Product Types.
  • Fixed an issue where responses to tabular questions could not be deleted without adding a new response.
Version 2.17.02 - Released April 9, 2015
Enhancements
  • CBER: Added support for multiple codes of "Illness at Time of Vaccination" within the VAERS Pilot template.
Fixes
  • CDER/CBER: Fixed an issue with Generic Drug Facility Electronic Self-Identification submission type output related to international phone numbers.
Version 2.17.01 - Released April 6, 2015
Enhancements
  • CBER: Released an updated CBER VAERS template and output capability for VAERS Pilot Participants.
  • CDRH: Updated product code, guidance, and standards lookup tables.
Fixes
  • None.
Version 2.16.02 - Released March 25, 2015
Enhancements
  • None.
Fixes
  • Fixed an issues related to the CDRH 510(k) template and international phone/fax numbers preventing the output from generating.
Version 2.16.01 - Released March 5, 2015
Enhancements
  • CTP: Updated the Ingredient Listing, Health Documents, Harmful and Potentially Harmful Constituents and the ESG Transmittal Form to collect a cover letter in a separate attachment question. Updated question text on existing attachment question and separated the Comments section to stand alone. Added a message to inform users of the changes.
  • Enhanced the HTML Submission Report output to include Expand/Collapse capabilities within section headers.
  • CDRH: Updated product code, guidance, and standards lookup tables.
Fixes
  • Fixed a header formatting issue within the Adobe PDF version of the Submission Report.
Version 2.15.01 - Released February 5, 2015
Enhancements
  • CBER: Updated the eSubmitter Electronic Participant Checklist to reflect new DCC mailing address.
  • CDRH: Updated product code, guidance, and standards lookup tables.
Fixes
  • CTP: Fixed an issue within the HPHC template where 'Other' text for mexthod of separation and detection were not properly being saved.
  • CDRH: Fixed an issue within the Report of Assembly of a Diagnostic X-Ray System submission so that a zip code extension is no longer required within the data entry.
Version 2.14.02 - Released January 12, 2015
Enhancements
  • CDRH 510(k): Adjusted the list of available file types that can be attached within a submission (e.g., removed support for Microsoft Word .docx files).
  • CDRH 510(k): Adjusted text within the template and eSubmitter to reflect the end of the CDRH 510(k) pilot. Going forward, only applicants that have already submitted submissions can continue to submit documentation via this eSubmitter template.
Fixes
  • None.
Version 2.14.01 - Released January 7, 2015
Enhancements
  • CDRH: Updated product code, guidance, and standards lookup tables.
Fixes
  • None.
Version 2.13.07 - Released January 2, 2015
Enhancements
  • None.
Fixes
  • CVM: Fixed an issue where eSubmitter submissions greater than 2 GB cause the ESS Mediator to "Hang" or become nonresponsive thus not processing the submission and making it available for review. Developed a viable solution to accommodate eSubmitter submissions that are up to 10 GB in size.
Version 2.13.06 - Released December 31, 2014
Enhancements
  • CBER: Added new approach to supporting Null Flavor capabilities within the ICSR template.
Fixes
  • None.

Version 2.13.05 - Released December 23, 2014
Enhancements
  • None.
Fixes
  • CVM: Fixed the issue preventing the activation of Node 5.0 in the INAD P-MC, JINAD P-MC, and ANADA A-OT templates.
Version 2.13.04 - Released December 19, 2014
Enhancements
  • CVM: Two modifications were made to both the I-P-NV and J-P-NV templates: 1) permit both PDF and XML files to be attached to Node 6.0 and 2) change the need for a file attachment from required to optional for Nodes 3.1, 3.3, 3.4, and 3.5.
  • CBER: General updates to the ICSR template and HL7 output message.
Fixes
  • None.

Version 2.13.03 - Released December 16, 2014
Enhancements
  • CVM: Implemented 1 GB submission file size limit. All submissions greater than 1 GB will be broken into multiple files that are less than 1 GB in size. Each ZIP file must be submitted separately through the ESG to complete the submission. Once all submission "pieces" are received, one CVM ESS receipt will be issued.
  • CVM: Allow the sponsor to attach the pharmaceutical development report as a PDF document in the following templates, J-P-MC, I-P-MC, A-A-OT.
  • CVM: Added a hint to Section 2.3.P.4.d, on the Excipient Manufacturer Details tab in the following templates J-P-MC, I-P-MC, A-A-OT.
  • CVM: Updated Chemistry Manufacturing and Controls technical section templates (I/P/MC and J/P/MC) and the A-A-OT template to permit identification of whether the sponsor is submitting a two phased submission.
  • CVM: Deleted the question in Section 2.3.P.3.a, "What are the quality standards for each component used in the manufacturing process?" in the following templates, J-P-MC, I-P-MC, A-A-OT, A-E-OT.
Fixes
  • An issue within the FDA production webserver that prevented downloads of the previous eSubmitter updates has been resolved.
Version 2.13.02 - Released December 9, 2014
Enhancements
  • CDRH 510(k): Added a question in Patient Contact Materials that request color additive information. This question is necessary according to the RTA Guidance document.
  • CDRH 510(k): Added ability to add Preamendment, Exempt, down-classified PMA, and De Novo submissions as predicates.
  • CDRH 510(k): Removed listing of the predicates as Related Submissions, they will be obtained separately within the SE Comparison section.
  • CDRH 510(k): The user may now choose to have the 510(k) Summary be produced automatically, using data entered throughout the template. The data used to produce the 510(k) Summary are clearly distinguished and advise in prominent text to not include confidential information in these sections, since the 510(k) Summary is made public if the submission is found SE.
Fixes
  • Fixed a report output and packaging issue involving international phone numbers.
Version 2.13.01 - Released December 5, 2014
Enhancements
  • CBER: General updates to the ICSR template and HL7 output message.
  • CDRH: Updated product code, guidance, and standards lookup tables.
Fixes
  • CDRH and CBER: Fixed an issue where dates earlier than 1950 were no longer supported (related to ICSR submission types).
Version 2.12.01 - Released November 7, 2014
Enhancements
  • CBER: Added support to enforce that Reaction/Event matrix items are always associated to an existing Drug and Reaction within the ICSR template and HL7 output message.
  • CBER: Added support for partial dates within the ICSR template and HL7 output message.
  • CBER: General updates to the ICSR template and HL7 output message.
  • CDRH: Updated product code, guidance, and standards lookup tables.
Fixes
  • None.

Version 2.11.01 - Released October 6, 2014
Enhancements
  • CBER: Updates to the ICSR template and HL7 output message.
  • CDRH: Added the OMB control number to ISO13485 template, The OMB control number is 0910-0700 and expires February 28, 2015.
  • CDRH: Updated product code, guidance, and standards lookup tables.
Fixes
  • None.

Version 2.10.01 - Released September 8, 2014
Enhancements
  • CVM: An administrative indicator was added to the following templates to address the AGDUFA II modifications: ANADA Supplement (A/C/B1), NADA Supplement (N/C/B1), and ANADA Original (A/A/OT).
  • CBER: Added product correspondence as a type of submission in Whole Blood and Blood Components submissions.
  • CDRH: Added a rule to the CDRH 510K submission type to ensure Other Regulations cannot contain a Class III product code unless also designated within the Primary Regulation.
  • CDRH: Updated product code, guidance, and standards lookup tables.
Fixes
  • CBER: Fixed the font size issue with the Whole Blood and Blood Components PDF submission report output.

Version 2.09.02 - Released August 22, 2014
Enhancements
  • None.
Fixes
  • CVM: The following templates were rolled back to the last version to the 6/13/14 release: ANADA Supplement (A/C/NF) and NADA Supplement (N/C/NF), to remove the ADUFA III specific questions that will not be available until 10/1/14.
Version 2.08.01 - Released July 7, 2014
Enhancements
  • CBER: Released CBER Individual Case Safety Reports (ICSR) to Production for VAERS Pilot Participants.
  • CBER: Updated the BLA submission mailing address and included an updated CBER eSubmitter Participant Checklist.
  • CDRH: Updated product code, guidance, and standards lookup tables.
Fixes
  • CDRH: Fixed an issue where standards did not always properly maintain the selected organization and year references.
Version 2.07.03 - Released June 13, 2014
Enhancements

CVM: In reauthorizing the Animal Generic Drug User Fee Act of 2013 and the Animal Drug User Fee Act of 2013, the FDA committed to provide enhancements to its review environment that include substantive changes to the Center for Veterinary Medicine's (CVM) Submission and Review System. The enhancements that were agreed to in this reauthorization are outlined in the Goals Letter.

This release will update the following templates for the Office of New Animal Drug Evaluation (ONADE).

Templates impacted by modifications for AGDUFA II:

  • A-E-OT, A-C-CS, J-P-BQ, J-P-HF, J-P-MC, J-P-NV, J-P-PE

Templates impacted by modifications for ADUFA III:

  • A-C-AS, A-C-B1, N-A-OT, N-C-B1, N-C-CS
Fixes
  • None.
Version 2.07.01 - Released June 5, 2014
Enhancements
  • CTP: Adjusted the CTP Document Control Center mailing address within the packaging dialog to reflect the new address for mailing CD submissions.
  • CDRH: Updated product code, guidance, and standards lookup tables.
Fixes
  • CDRH: Fixed an issue within the MedWatch submission output that didn't properly differentiate between the manufacturer contact and site (i.e., G1 and G2) when site information was available but no contact information was provided.
  • CDRH: Fixed an issue within eCopies to remove certain special characters (e.g., pound, tilde, single quote) from file names before generating the submission output.
Version 2.06.01 - Released May 5, 2014
Enhancements
  • CDRH: Released new electronic Premarket Notification 510(k) Pilot template.
  • CDRH: Adjusted the eCopies template to use a simpler file attachment approach.
  • CDRH: Updated product code, guidance, and standards lookup tables.
Fixes
  • CVM: Fixed an issue where international phone numbers were formatted incorrectly within the HTML report output.
Version 2.05.02 - Released April 28, 2014
Enhancements
  • None.
Fixes
  • CVM: Fixed an issue where data was lost when updating the Document Number.
Version 2.05.01 - Released April 7, 2014
Enhancements
  • CDRH: Updated the OMB form expiration date to January 31, 2017.
  • CDRH: Updated product code, guidance, and standards lookup tables.
Fixes
  • CTP: Fixed an issue where numbers being imported from a spreadsheet within a tabular node were failing to import properly due to extra spaces appearing before or after the numbers in the spreadsheet cell.
  • Fixed an issue where when switching between views (i.e., Simple and Expert) sometimes the contents of the current data entry would become cut-off from the bottom of the screen. This only occurred when the screen was long enough to require vertical scrolling.
Version 2.04.02 - Released March 10, 2014
Enhancements
  • None.
Fixes
  • CVM: Core Questions template version 1.11 reflects updates to the Welcome Screen upon opening a submission. The new welcome screen displays the OMB Number expiration dates with an expiration end date of 2016. The CVM address line 1 has also been updated to reflect a corrected mailing address number. This change applies to all ONADE submissions.
Version 2.02.02 - Released January 29, 2014
Enhancements
  • None.
Fixes
  • CVM: Business Rules have been added to eSubmitter for the following submission types to show Reference Listed Product enabled and required: A-C-AC, A-C-CC, A-C-NL, A-C-NF, A-R-AC, A-R-CC, A-R-NL, A-R-NF, A-R-B1.
Version 2.02.01 - Released January 6, 2014
Enhancements
  • CDRH: Updated product code, guidance, and standards lookup tables.
Fixes
  • CVM: The following templates were rolled back to the last version prior to the 9/12/13 release: INAD Major Technical Section (I-P-MC), JINAD Major Technical Section (J-P-MC), and ANADA Original (A-A-OT). As a result of the 9/12/13 release, questions become disabled (grayed out) preventing required information to be entered. The errors were introduced with the "two phased data submission" questions that were added to these templates. These questions will be added back to the templates in a future release.
Version 2.01.01 - Released December 5, 2013
Enhancements
  • CTP: Updated the quantity fields in the CTP’s HPHC and Ingredient templates and import spreadsheets to allow for greater flexibility in data entry.
  • CVM: Added HFV-160 to the LOV for Review Division on the Submission Type tab for all INAD H submissions.
  • CDRH: Updated product code, guidance, and standards lookup tables.
Fixes
  • CTP: Fixed an import issue on the HPHC template that was dropping the last picklist value upon import.
Version 2.00.01 - Released November 5, 2013
Enhancements
  • All: Added new keyboard navigation support so that longer screens will auto-scroll vertically when tabbing through questions with the keyboard.
  • All: Added new keyboard short-cut support to table screens (see the new Table option in the main menu for details).
  • All: Added new keyboard outline support for navigating directly to a parent node (Ctrl->M).
  • CDRH: Removed the password and embedded attachment validation from eCopies submissions.
  • CDRH: Minor updates to the RadHealth templates.
  • CDRH: Updated product code, guidance, and standards lookup tables.
Fixes
  • CTP: Fixed an HPHC template issue related to Benzo[a]preen and Benzene and Smokeless products.
  • CTP: Fixed an issue related the import of large numbers being converted to exponential notation.
Version 1.99.01 - Released September 12, 2013
Enhancements
  • CVM: Additional question added to the I/P/MC, J/P/MC, and A/A/OT templates to support two phased CMC submissions.
  • CDRH: Updated product code, guidance, and standards lookup tables.
Fixes
  • None.
Version 1.98.02 - Released August 21, 2013
Enhancements
  • None.
Fixes
  • CTP: The CTP ESG Transmittal form’s list of submission types was updated.
  • CBER: Minor update to the Investigational New Drug (IND) Application template.
Version 1.98.01 - Released August 16, 2013
Enhancements
  • CVM: OMUMS submissions (I, L, N) are now active and are directed to the appropriate review division.
  • CVM: Minor hint updates to Core Questions.
  • CVM: Additional questions added for J/P/HF and I/P/HF.
  • CTP: Added a new field to CTP’s ESG Transmittal Form which allows Industry to specify their submission type.
  • CTP: Updated the CTP’s HPHC Import Spreadsheets to include an edition date.
  • CDRH: Updated product code, guidance, and standards lookup tables.
Fixes
  • None.
Version 1.97.01 - Released July 19, 2013
Enhancements
  • CBER: Released CBER’s Investigational New Drug (IND) Application, including Antivenin INDs, in eCTD Structured Format.
  • CDRH: Updated FDA Form Numbers in RadHealth templates.
  • CDRH: Updated product code, guidance, and standards lookup tables.
Fixes
  • Updated CTP’s User Support phone number in all production templates.
Version 1.96.02 - Released June 27, 2013
Enhancements
  • None.
Fixes
  • CVM: Fixed minor issue with N-C-NL template.
Version 1.96.01 - Released June 11, 2013
Enhancements
  • CDRH: Updated product code, guidance, and standards lookup tables.
Fixes
  • CVM: Minor updates to the following ONADE templates: Core Questions, Original ANADA (A/A/OT), Study Template (MC), Chemistry Report (B/F), Supplement (C), Reactivation of Supplement (R), Protocol (BQ), and Supporting Information (H).
Version 1.95.01 - Released May 17, 2013
Enhancements
  • CDRH: Updated the Paperwork Reduction act statement in the Radhealth product report template.
  • CDRH: Updated product code, guidance, and standards lookup tables.
Fixes
  • CTP: Fixed an issues related to missing data and the Tobacco Registration and Listing and Product Ingredient Listing submission types.
  • CDRH: Fixed an issue where contact/establishment addresses required a state/province/territory for international addresses when it should no longer be required.

Previous Updates

Page Last Updated: 07/10/2015
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