Blog
RSS FeedPosted by Michael Wonder on 11 Oct 2017
CDR Update — Issue 129
11 October 2017 - In August 2017, CADTH invited stakeholder comments and feedback on a proposal to revise the resubmission ...
Posted by Michael Wonder on 04 Oct 2017
Countdown to launch of new EudraVigilance system
4 October 2017 - Final preparations for change-over to new system underway for go live date on 22 November 2017 ...
Posted by Michael Wonder on 02 Oct 2017
Revised procedure for advance notification of pending CDR submissions and resubmissions
28 September 2017 - In September 2016, CADTH updated the advance notification procedure for the Common Drug Review. ...
Posted by Michael Wonder on 29 Sep 2017
FDA improves access to reports of adverse drug reactions
28 September 2017 - New online tool makes it easier for users to search the FDA Adverse Event Reporting System. ...
Posted by Michael Wonder on 26 Sep 2017
TGA and PBAC parallel process now available for vaccines
26 September 2017 - Vaccines that meet certain requirements are now eligible to be submitted under the TGA and PBAC ...
Posted by Michael Wonder on 05 Sep 2017
Introduction of mandatory arrangements for PBS Efficient Funding of Chemotherapy claims
5 September 2017 - From 1 December 2017, approved suppliers will be required to enter a compounder ID when submitting ...
Posted by Michael Wonder on 01 Sep 2017
Provisional approval pathway for prescription medicines
1 September 2017 - The TGA would like to thank respondents who provided submissions in response to the March 2017 ...
Posted by Michael Wonder on 09 Aug 2017
Comprehensive assessment of complex technologies: integrating various aspects in health technology assessment
7 August 2017 - Despite recent development of health technology assessment (HTA) methods, there are still methodological gaps for the assessment ...
Posted by Michael Wonder on 01 Aug 2017
Proposed revisions to CADTH’s biosimilar review process
1 August 2017 - Given the type of data required to support biosimilar authorization differs from that required for a biologic ...
Posted by Michael Wonder on 24 Jul 2017
Managing conflicts of interest – making good decisions
24 July 2017 - NICE is seeking views on a new conflicts of interest policy to ensure its committees’ decisions ...
Posted by Michael Wonder on 13 Jul 2017
Proposed revision to the procedure for the CADTH Common Drug Review and the CADTH Therapeutic Review Framework
13 July 2017 - CADTH is inviting stakeholder comments and feedback on proposed revisions to the Procedure for the CADTH Common ...
Posted by Michael Wonder on 01 Jul 2017
Revised dispensing of PBS items for nursing home residents
30 June 2017 - Commencing July, pharmacists should include the RACFId for the nursing home each time a PBS/RPBS item ...
Posted by Michael Wonder on 26 Jun 2017
Priority review pathway: prescription medicines
26 June 2017 - As part of the Government's response to the Review of Medicines and Medical Devices Regulation (MMDR review), ...
Posted by Michael Wonder on 13 Jun 2017
Integrating companion diagnostics into CDR and pCODR reviews
13 June 2017 - In November 2016, CADTH invited stakeholder comments and feedback on a proposed process for the assessment ...
Posted by Michael Wonder on 11 Jun 2017
Subsequent entry products for non-biological complex drugs
9 June 2017 - In order to reflect the current environment for subsequent entry non-biological complex drugs, CADTH, in consultation ...