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 2.17.02 - 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.
Version 1.94.02 - Released April 23, 2013
Enhancements
  • None.
Fixes
  • CVM: Minor update to the CMC template.
  • CDRH: Fixed an issue where data could be lost within the technical section of a Rad Health Product Report submission (sections: 4.6.1, 4.7.3, 4.7.4, 5.7, and 6.6).
  • CDRH: Adjusted the description of the eCopies submission type.
  • CDER: Removed the SPL Establishment Registration and Product Listing templates. Please refer to the FDA website for information on using Xforms for future SPL Establishment Registration and Product Listing submissions.
  • CTP: Updated 904(a)(3) template to include hyperlinks to OMB Forms on FDA website.
Version 1.94.01 - Released April 5, 2013
Enhancements
  • Released CVM template for Original VMF (V/A/OT) submissions.
  • Released CTP’s eSubmitter template for Reporting Harmful and Potentially Harmful Constituents.
  • Released CTP’s ESG Transmittal form to allow for the data entry of person information for a Company and a Submitter.
  • Added support for including periods in file attachment descriptive titles.
  • Enhanced the international phone number support by adding a descriptive hint describing the individual data entry sections, as well as replacing the spaces between sections with a hyphen for clarity.
  • Updated product code, guidance, and standards lookup tables.
Fixes
  • CDRH: Fixed the Volume and Submitter Marker file issues related to eCopies submissions.
  • CDER: Fixed an issue where some international phone numbers were output incorrectly in the HL7 SPL message.
  • Fixed an issue where contact/address information was not always being copied up to the contact book successfully.
  • Adjusted the international phone number data entry to only support digits and spaces. Spaces are allowed in order to complete a section that contains less data then allowed (e.g., a country code with only two digits when three digits are allowed).
Version 1.93.01 - Released March 7, 2013
Enhancements
  • Updated product code, guidance, and standards lookup tables.
Fixes
  • CVM: Minor updates to Core questions to include HFV-160 for INAD and NADA Y/Z submissions.
  • CVM: New question added to the following templates: Original ANADA, Reactivation of Original ANADA, Original NADA, Reactivation of Original NADA, Supplement B1, Supplement ANADA B1, Reactivation of Supplement B1, and Reactivation of Supplement ANADA B1.
Version 1.92.02 - Released February 22, 2013
Enhancements
  • None
Fixes
  • CVM ONADE: Minor updates to the following templates: Core Questions, CMC, Food Use Authorizations (Original and Amended), Supplement, Reactivation of a Supplement, Original NADA, Reactivation of Original NADA, Original ANADA, Reactivation of Original ANADA, Original VMF, and VMF Supplement.
  • CVM ONADE: Disabled MUMS submissions.
Version 1.92.01 - Released February 5, 2013
Enhancements
  • Updated product code, guidance, and standards lookup tables.
Fixes
  • None
Version 1.91.02 - Released January 18, 2013
Enhancements
  • CVM ONADE: Adjusted Veterinary Master File document types to support IVET innovative initiative file submissions.
Fixes
  • CVM ONADE: Minor updates to the following templates: Core Questions, CMC, Food Use Authorizations (Original and Amended), Supplement, Reactivation of a Supplement, Original NADA, Reactivation of Original NADA, Original ANADA, Reactivation of Original ANADA, Original VMF, and VMF Supplement.
  • CVM ONADE: Disabled MUMS submissions.
Version 1.91.01 - Released January 7, 2013
Enhancements
  • Updated product code, guidance, and standards lookup tables.
Fixes
  • CDER: Temporarily removed the CDER ICSR template while it is under maintenance.
  • CDRH: Update the website link in ISO13485 template.
Version 1.90.01 - Released December 5, 2012
Enhancements
  • Updated product code, guidance, and standards lookup tables.
Fixes
  • CDER: Fixed an issue where the version number within an SPL submission wouldn't allow a zero in the response.
Version 1.89.01 - Released November 5, 2012
Enhancements
  • Updated product code, guidance, and standards lookup tables.
Fixes
  • CVM ONADE: Minor updates to Meeting Request, CMC, and NADA/ANADA Supplement and Reactivation of Supplement submissions.
  • CVM ONADE: Added an import function on G-AD submissions for all document types.
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

Previous Updates

Page Last Updated: 04/13/2015
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