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12

Mar2015
Category 1 requirements for products that undergo a tailored CDR review have been revised. Submissions for new combination products (funded components) and new combination products designated by CADTH to undergo a tailored CDR review will require completion of the revised New Combination Product Submission Template.  This revised template ... Read More

05

Mar2015
CADTH will be implementing an application fee for manufacturer applications filed with the pan-Canadian Oncology Drug Review (pCODR). The proposed fee will apply to all manufacturer applications with a Health Canada Notice of Compliance (NOC) or Notice of Compliance with Conditions (NOC/c) date of April 1, 2015 or later. The ... Read More

04

Feb2015
Pilot Extension for Individual Patient Input to the Common Drug Review The Common Drug Review (CDR) is extending its pilot to receive patient input submissions from individual patients and caregivers until August 3, 2015. Pilot Extension for Patient Input for Therapeutic Reviews CADTH implemented a pilot process for receiving patient input submissions for ... Read More

05

Jan2015
Common Drug Review The Canadian Agency for Drugs and Technologies in Health posted the Canadian Drug Expert Committee (CDEC) final recommendation for its first review of a subsequent entry biologic on its website yesterday. Below is an excerpt from the CDEC Final Recommendation. Recommendation: ... Read More

03

Oct2014
Common Drug Review patient input submission system CADTH has added new safeguards allowing them to better track submissions automatically: Online & email confirmations for successful uploads Submissions can now be uploaded until midnight on the date of the specified deadline, in all Canadian time zones   2015 CADTH Symposium CADTH is offering funding to help patient ... Read More

16

Sep2014
The Canadian Agency for Drugs and Technologies in Health (CADTH) revised its Guidelines for Manufacturers on Application Fees for the Common Drug Review. A draft version was circulated for stakeholder feedback in July, following which the below key changes were made: Fees for resubmission based on new clinical information ... Read More

06

Aug2014
Direct-Acting Antivirals for Chronic Hepatitis C Genotype 1: Draft recommendations posted, feedback requested Yesterday the Canadian Agency for Drugs and Technologies in Health (CADTH)posted on its website the draft Canadian Drug Expert Committee (CDEC) recommendations report stemming from itsrecent therapeutic review project to assess the clinical and economic impact ... Read More

31

Jul2014
The Canadian Agency for Drugs and Technologies in Health (CADTH) is requesting stakeholder feedback on its draft guidance document, released today, concerning its recent announcement to introduce industry application fees for manufacturer submissions and resubmissions made to the Common Drug Review. The draft Guidelines for Manufacturers on Application Fees ... Read More

30

Jul2014
An updated table with the targeted Canadian Drug Expert Committee (CDEC) meeting dates is now available on the CADTH website A CDEC meeting will be held in December 2014 as part of an initiative to eliminate an accumulation of CDR submissions. CADTH is extending the pilot process for receiving patient input ... Read More

08

Jul2014
Effective July 2, 2014, patient groups will now have 35 business days to prepare and submit their patient input submissions to CDR This is possible due to the mandatory pre-submission advance notice policy which will be going into effect the same day. As per the policy, manufacturers must provide a minimum ... Read More