ONADE: Released a new template to support the electronic receipt of submissions for the determination of eligibility (I-G-DE).
ONADE: Included revisions to the Blood Level Bioequivalence Major Technical Section QbR template (J-P-BQ), as well as now supporting all the J-P-BQ QbR capabilities within an Original ANADA submission (A-A-OT).
ONADE: Fixed an issue where the CMC Major Technical Section tab was not properly unloaded within an A-A-OT submission when switching to an Administrative ANADA.
Fixed an issue where HFV-170 could not be selected as the primary review division for ANADA B1 supplements and reactivations (A-C-B1, A-R-B1).
ONADE ABCT: Added HFV-180 as a review division option within the following ABCT submission types (I/G/N/V)-G-AD, (I/G/N/V)-G-OT, (I/G/N/V)-G-TM, (I/G/N)-Z-OM, and (I/G/N)-Y-OM.
ONADE ABCT: Included "Recombinant DNA Technology" section within ABCT I-X-(CE/EA) submission types when only IGA is selected as a product category.
ONADE: Updated the Electronic Submission System (ESS) - Acceptance and Rejection Messages document to include corrective actions for common submission issues. A reference to the revised document is now available within the eSubmitter "Alerts and News" and "Frequently Asked Questions".
ONADE: Adjusted the Original ANADA and NADA submission types to automatically require the Environmental Technical Section.
ONADE: Removed redundant questions from with (I/J)-P-NV submission types.
ONADE ABCT: Added a new "Other Information, Reports, or Requests" option to the information contained within the submission question of the ABCT Type VII VMF Supplement submission type (V-C-OT).
ONADE: Removed the labeling type submitted question with the response options of Final Printed Labeling (FPL), Facsimile Labeling, or Combination of FPL and Facsimile Labeling from several submission types where it is no longer relevant (i.e., A-C-B1, A-R-B1, A-A-OT, A-E-OT, A-C-NL, N-A-OT, N-E-OT, N-R-B1, N-R-NK, N-C-B1, N-C-NL).
ONADE: Added a popup warning message to CMC submission types where document linking was recently included, to remind sponsors that by providing additional documents they are creating linked submissions, which will duplicate all the information provided in the current submission to all the additional documents/applications referenced.
ONADE: Added a new popup message within the ONADE/ABCT core templates to provide additional clarity on when it is appropriate to select "Yes" to the amendment option to amend a submission currently pending and under review by CVM.
ONADE: Revised the formulation questions within the Test and Control Article Characterization section of the INAD Effectiveness (I-P-EF) and Target Animal Safety (I-P-TS) templates.
ONADE: Fixed an issue within the Blood Level Bioequivalence Major Technical Section template (J-P-BQ) that resulted in missing data issues when created using the "Save-As" feature from a submission based on the older template structure.
ONADE: Release of submission template for import tolerance (VMF) files.
ONADE: Fixed an issue where file attachments removed from the submission file list were not always removed from associated question responses (i.e., the issue was specific to I-P-EF and I-P-TS submission types).
ONADE ABCT: Added a new question within the ABCT I-A-OT and V-A-OT submission types to allow sponsors to request enrollment in the Veterinary Innovation Program (VIP).
ONADE: Fixed an issue within CMC Technical Section submissions where section 2.3.P.4.d "Excipient Manufacturer" was incorrectly activated when selecting "Yes" to "Does the product contain excipients?" when it should only have been activated when selecting "Yes" to "Are any novel excipients being utilized?".
ONADE: Fixed an issue within A-E-OT submissions where section 3.3.7 "Marketing Exclusivity" was not being activated when selecting "Patent Certification and Marketing Exclusivity" from within section 3.0 "Technical Section".
ONADE: Fixed an issue where the Responsible Official phone number was incorrectly formatted within the Submission Report.
ONADE ABCT: Fixed issues within the review division selection list for several ABCT INAD and VMF submission types.
ONADE: Updated all "Z" meeting templates (I-Z-OM, N-Z-OM, A-Z-OM, J-Z-OM, G-Z-OM, and V-Z-OM) to enable contact/address book support when identifying contacts to include as Firm Participants in Section 4.0.
All: Added hyperlink support to email addresses within the eSubmitter Submission report to auto-generate a pre-addressed email using the default email client application.
ONADE: Removed the CBE-30 question from CMC submission types where it was incorrectly made available: Chemistry Supplement, Immediate Change Being Effected (A-C-AI, A-C-CI, N-C-CI) and Prior Approval (A-C-AP, A-C-CP, N-C-CP).
ONADE: Fixed an issue where names containing over 25 characters were truncated within the digital signature of the administrative cover sheet included within eSubmitter submission packages.
ONADE: Fixed an issue within the Notice of Shipment template (I-B-OT) where Sub-Class and Class Other text information were inadvertently cleared when exiting and re-entering Section 1.3 "Type and Number of Animals".
ONADE: Fixed an issue where RLNAD information was incorrectly disabled within the following submission types: A-C-NL, A-C-NF, A-R-AC, A-R-CC, J-H-OT, and J-H-SP
ONADE: Removed section 4.9 "Microbiological Testing Controls" (and associated sub-sections) from the V-A-OT template, since they reference information not commonly provided within a Type V Master file.
ONADE: Fixed an issue within some CMC submissions where the purpose of submission within the administrative cover sheet was missing.
ONADE: Updated the A-Z-OM, J-Z-OM, G-Z-OM, and V-Z-OM "Z" meeting templates to reflect the meeting type, audio/visual requirement, and requested CVM participant enhancements previously incorporated in the I-Z-OM and N-Z-OM templates.
ONADE: Updated all "Z" meeting templates (I-Z-OM, N-Z-OM, A-Z-OM, J-Z-OM, G-Z-OM, and V-Z-OM) to only require the status of foreign visitors when requesting and in person meeting.
ONADE ABCT: Released INAD major technical section template: Phenotypic Characterization (TS) for use within ABCT submissions.