Business Impact of 「ジャック」’s Conditions of Approval and Use-Results Survey
First written in FY2016. 3 of 5 entries say "Mitigated", first in FY2020. Latest entry: FY2024.
0 other companies' latest entry also says "Mitigated".
- FY2024MitigatedAnnual report
「In June 2022, the re-examination of the post-approval use-results survey was completed, reconfirming the efficacy and safety established at the time of approval.」
The disclosure again describes the completion of the re-examination of JACC's 7-year use-results survey and confirmation of its efficacy and safety, reducing uncertainty surrounding the approval conditions. - FY2023-Q2RestatedAnnual report
「In June 2022, the re-examination of the post-approval use-results survey was completed, reconfirming the efficacy and safety established at the time of approval.」
The company continues to disclose the completion of the re-examination of JACC's use-results survey and confirmation of its efficacy and safety. - FY2023-Q1MitigatedAnnual report
「In June 2022, the re-examination of the post-approval use-results survey was completed, reconfirming the efficacy and safety established at the time of approval.」
For JACC, the re-examination of the post-approval use-results survey was completed, and confirmation of the efficacy and safety established at approval further reduced uncertainty surrounding the approval conditions and post-marketing surveillance. - FY2020MitigatedAnnual report
「A 7-year use-results survey covering all cases was required for this product, but the survey registration period ended during the fiscal year under review.」
For JACC, the registration period for the 7-year use-results survey has ended, representing further progress regarding the approval conditions. The application for re-examination was submitted in October 2019. - FY2016First statedAnnual report
「If these results reveal a material safety problem with the product or fail to demonstrate efficacy, the approval could be revoked, which could have a material impact on the company's business strategy and business performance.」
The company identifies facility standards, physician requirements, the all-case use-results survey, and the collection of safety and efficacy data as risks associated with the approval conditions.