ONADE ABCT: Added the I-P-NV template under the ABCT program, so I-P-NV submissions can be created from the ABCT Core template.
ONADE: Added new Waiver Submission Type for General Correspondence Supplement (G-C-GF) and Reactivation (G-R-GF) to support AGDUFA Filing Fee.
ONADE: Added a question to determine if a G-Z-OM submission relates to a specific drug product. If yes, the Product Description tab is displayed.
ONADE: Adjusted the submission classification code text related to an N-G-OT submission from "Conditional Annual Approval Renewal Request (OT)" to "Conditional Approval Renewal Request (OT)".
ONADE ABCT: Adjusted the ABCT Core template to ensure the Product Information tab is available within all ABCT Major Technical Section submissions.
ONADE: Changed the option selection text within question “Please designate the timing of the protocol you anticipate for the H-SP submission” of the INAD Support of Protocols (I-H-SP) submission type to provide additional clarity.
ONADE: Changed the wording within (A)NADA submissions that accept technical section complete letters to reference a letter or memorandum of conference to provide increased flexibility in the types of letters uploaded.
ONADE: Fixed an issue where JINAD Filing Fee questions were incorrectly displayed within the CMC technical section of an original ANADA when there is not a CMC Technical Section Complete Letter available.
ONADE: Added support for backing up, restoring, and synching across repositories eSubmitter book content (i.e., Product Book, Master File Book, ADMS Establishment Book, ADMS Supply Chain Book, and Contact/Establishment Books).
ONADE: Updates to section 3.0 "U.S. Agent/U.S. Employee Information" of the Core template:
Changed the text of the first question from "Select your role" to "Select role of the Responsible Official"
Changed the first role selection option from "U.S. - Based Employee" to "U.S. - Based Employee or Representative"
Changed the text of the contact information question from "Please enter Contact Information on the role selected above" to "Please enter contact information for the Responsible Official identified above"
ONADE: Updated the Support Protocol (I-H-SP) submission type to provide additional clarity regarding Early Information (EI) submissions, as well as added a question to capture the submission ID within related protocol submission types (I-E-TS/EF/MC/NV/HF/XE) when an "H" submission precedes the protocol.
ALL: Replaced the existing File Specifications document with a new "Acceptable File Types for CVM eSubmitter User Guide".
ONADE: Fixed an issue with the entry of document types and numbers within section 1.0 “General Information” of the Original ANADA (A-A-OT) submission type.
ONADE: Removed the entry of document types and numbers within section 1.0 "General Information" of the Reactivation of Original ANADA (A-E-OT) submission type since it is not applicable.
ONADE: Added question to upload Letter of Authorization for a US Agent on Initial (J)INAD (I-A-OT) and Original (A)NADA (A-A-OT) submission types where US Agent is the selected role.
ONADE: Added the ability to attached a list of authorized users to the VMF Supplemental (V-C-OT) submission type.
DABCT: Added investigator contact information to the Type VII VMF Supplemental (V-C-OT) submission type.
DABCT: Removed the DABCT submission type, major technical section claim validation (I-P-CV), from the ABCT Core template to align with the draft of GFI 187.
DABCT: Updated the Cell-Based Product options within the Product Characterization Technical Section (I-P-PC) submission type to only include Characterization Module, Donor Eligibility Module, and Comparability Module.
ONADE: Temporarily removed new submission type (I-C-IB) to initiate a project under an INAD for a future N-C-B1 approval since it was inadvertently released before being fully supported.
ONADE/ABCT: Added question to capture the payment identification number to Original (A/N-A-OT) and B1 Supplement (A/N-C-B1) submission types.
ONADE/ABCT: Added question for capturing associated (J)INAD document numbers to Original (A/N-A-OT) and B1 Supplement (A/N-C-B1) submission types.
ONADE: Added question to capture User Fee Coversheet attachment and payment number to Initial JINAD (J-A-OT) and Major Technical Sections for Bioequivalence (J/P/BQ) and Chemistry, Manufacturing and Controls (J/P/MC) submission types.
ONADE: Added a new submission type (I-H-RD) to provide a proposed list of raw data and documents to be submitted with the associated FSR for a TAS study under an INAD.
ONADE/ABCT: Added an option to allow Firms to receive an early response letter (ERL) when they chose a virtual meeting (N/I-Z-OM) and opt in to the early response.
ONADE: Added a new submission option for ONADE Communication to enable the animal drug industry to respond to an Early Response Letter received during the review of Investigational New Animal Drug (INAD) or New Animal Drug Application (NADA) meeting submissions.
ONADE: Adjusted the Request for Written Feedback (I-H-OT) submission type and relocated it under Project Development (I-C-WF).
ONADE: Added a new submission type to initiate a project under an INAD for a future N-C-B1 approval (I-C-IB).
ONADE/ABCT: Added a new INAD submission type to allow sponsors to submit information in support of a meeting (I-H-MS).
ONADE: Updated the classification code for Excipient Evaluation submissions from J-G-OT to J-G-EX.
OMUMS: Updated the date of the OMB number covering the collection of information for OMUMS to meet FDA guidelines.
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