CADTH has posted its Guidelines for Manufacturers on Application Fees for the CADTH pan-Canadian Oncology Drug Review on its website, after stakeholder comments and feedback were received last month.
Key changes made in response to stakeholders’ comments are detailed in CADTH’s April 1, 2015 notice of implementation.
For ... Read More
07
Apr2015
25
Mar2015
Effective April 1, 2015, the pCODR office will be moving to 154 University Avenue, Suite 300, Toronto from its current location at 1 University Ave, Suite 300. This move is to facilitate pCODR’s transition to CADTH while maintaining its central location in downtown Toronto.
Please note the new main telephone and fax ... Read More
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