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 1.94.02 - 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