ONADE: Added an optional environmental assessment attachment option to administrative (A)NADA submissions when including an environmental technical section complete letter.
ONADE: Adjusted CMC related templates to allow sponsors to identify all other relevant files and applications related to a change submission, including those related to other centers.
ONADE: Updated the file attachment question within the G-G-OT submission type to be a multi-file type that supports all file types (e.g., permitting CSV files to be attached for providing milestone reports).
ONADE: Updated the ADMS guidebook to describe the process of importing ADMS information returned by CVM.
ONADE: Updated the file attachment questions within the technical sections of pre-submission conference meeting submission types (I/N-Z-OM) to be a multi-file type that supports all file types (e.g., permitting video files).
ONADE: Adjusted sponsor specified multi-file questions within submissions (e.g., labeling, freedom of information, further information, protocol amendments/deviations) to visibly show additional rows within the file list (i.e., now showing 10 rows instead of the default of 3 rows).
ONADE: Fixed the CVM ADMS XML import to prevent the subdivision of the firm address from being overwritten/cleared within the sponsor ADMS Establishment Book when a subdivision is returned that does not exist in the GENC list within eSubmitter.
ONADE ABCT: Fixed an issue where ABCT INAD Reasonable Expectation of Effectiveness (I-E-XE) submissions were failing to be processed when received.
All: Added new file types that can be attached within eSubmitter submissions, the new file types are as follows:
Image File (JPG)
Video File (MP4)
Audio File (MP3)
Comma Separated Value Data File (CSV)
Standard Text File (TXT)
ONADE: Updated the J-R-OT submission template to reorganize sections and questions, as well as to align with the active ingredient list within the product description.
ONADE: Updated text within section 3.0 "Information to Support Bioequivalence Technical Section" of the J-P-BQ submission template to directly ask if the sponsor is requesting a waiver from the requirement to perform in-vivo blood level bioequivalence study(s) for additional generic drug product strength(s) based on comparative dissolution data.
ONADE: Updated the ADMS missing data validation to require a minimum of one DS manufacturer, one DS tester, one DP manufacturer, and one DP tester within the following submission types: I/J-P-MC, N/A-A-OT, N/A-E-OT, and N/A-C-B1.
ONADE: Fixed the ESG User Guide link within the eSubmitter "Getting Started" dialog.
ONADE: Updated the A-A-OT submission template to allow the FOI file attachment to be optional within section 4.0 "Freedom of Information Summary" for administrative ANADA submissions.
ONADE: Updated the J-E-BQ submission template to include minor text changes in sections 1.0 "General Information" and 3.0 "Test Article", as well as restructuring of the questions within sections 26.0 "Statistical Methods" and the addition of a new section 26.1 "Analyte and Corresponding Statistical Methods".
ONADE: Fixed an issue where the section list used when amending a J-A-OT submission was either incorrect or blank, resulting in an inability to package due to missing data.
ONADE: Fixed an issue with the clearing of the Establishment Use Code when importing ADMS information returned by CVM to the sponsor as part of CVM’s submission response after a submission review is completed.
All: Added font scaling to the eSubmitter application to support the variety of screen size/resolution combinations used by industry sponsors. Font scaling can be activated using the following approaches:
Zoom option under the View menu for immediate one time use
Zoom setting under the Layout tab of the Preferences dialog to set the default zoom factor for all time use
ONADE: Fixed an issue where the section list used when amending V-C-AC/MC/MR submissions were blank, resulting in an inability to package due to missing data
ONADE: Fixed an issue where the I/J-D-OT submission template was not properly loading after the December 2022 release
ONADE: Fixed issues related to the import of ADMS information returned by CVM to the sponsor as part of CVM's submission response when a submission review is completed:
Issue where leading zeros omitted from a document number in the returned ADMS response failed to identify the corresponding document in the sponsor's Product Book
Issue where inspection and contact information was being cleared from within the sponsor's ADMS Establishment Book after the ADMS import