Canada’s Drug Agency | Drugs, Health Technologies and Systems.

benralizumab

Details

Key Milestones2
Call for patient input posted January 25, 2018
Patient group input closed March 16, 2018
Clarification:

- Patient input submission received
Patient input summary sent for review to patient input groups March 23, 2018
Patient group comments on input summary closed April 02, 2018
Clarification:

- Patient input summary feedback received
Submission received February 23, 2018
Submission accepted for review March 09, 2018
Review initiated March 12, 2018
Draft CDR review report(s) sent to applicant May 25, 2018
Comments from applicant on draft CDR review report(s) received June 05, 2018
Redaction requests from applicant on draft CDR review report(s) received June 13, 2018
Clarification:

- Extension requested by applicant

- Request granted
CDR review team's comments on draft CDR review report(s) sent to applicant July 06, 2018
Canadian Drug Expert Committee (CDEC) meeting July 18, 2018
CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plans July 30, 2018
Embargo period ended and validation of redacted CDR review report(s) received August 14, 2018
CDEC Final Recommendation issued to applicant and drug plans August 21, 2018
CDEC Final Recommendation posted August 23, 2018
Final CDR review report(s) and patient input posted August 31, 2018
Last Updated : January 16, 2019

lumacaftor/ivacaftor

Details

Key Milestones2
Call for patient input posted January 24, 2018
Patient group input closed March 15, 2018
Clarification:

- Patient input submission received
Patient input summary sent for review to patient input groups March 26, 2018
Patient group comments on input summary closed April 03, 2018
Clarification:

- Patient input summary feedback received
Submission received February 22, 2018
Submission accepted for review March 08, 2018
Review initiated March 09, 2018
Draft CDR review report(s) sent to applicant May 29, 2018
Comments from applicant on draft CDR review report(s) received June 07, 2018
Redaction requests from applicant on draft CDR review report(s) received June 14, 2018
CDR review team's comments on draft CDR review report(s) sent to applicant July 06, 2018
Canadian Drug Expert Committee (CDEC) meeting July 18, 2018
CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plans August 01, 2018
Embargo period ended and validation of redacted CDR review report(s) received August 16, 2018
Clarification:

- Request for Clarification received from CDR Participating Drug Plans
Drug plans' request for clarification placed on CDEC agenda September 19, 2018
Response to request for clarification and CDEC Final Recommendation sent to applicant and drug plans September 26, 2018
CDEC Final Recommendation posted October 04, 2018
Clarification:

- Target posting of CDEC Final Recommendation October 4, 2018
Final CDR review report(s) posted October 12, 2018
Last Updated : November 19, 2018

Levodopa / carbidopa (Drug Plan Submission)

Details

Key Milestones2
Call for patient input posted January 11, 2018
Patient group input closed March 02, 2018
Clarification:

- Patient input submission received
Patient input summary sent for review to patient input groups March 14, 2018
Patient group comments on input summary closed March 21, 2018
Clarification:

- Patient input summary feedback received
Submission received February 08, 2018
Submission accepted for review February 23, 2018
Review initiated February 26, 2018
Draft CDR review report(s) sent to applicant May 10, 2018
Comments from applicant on draft CDR review report(s) received May 22, 2018
Redaction requests from applicant on draft CDR review report(s) received May 29, 2018
CDR review team's comments on draft CDR review report(s) sent to applicant July 06, 2018
Canadian Drug Expert Committee (CDEC) meeting July 18, 2018
CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plans July 31, 2018
Embargo period ended and validation of redacted CDR review report(s) received August 15, 2018
CDEC Final Recommendation issued to applicant and drug plans August 22, 2018
CDEC Final Recommendation posted August 24, 2018
Final CDR review report(s) and patient input posted September 18, 2018
Last Updated : January 14, 2019

abobotulinumtoxinA

Details

Key Milestones2
Call for patient input posted January 03, 2018
Patient group input closed February 22, 2018
Clarification:

- Patient input submission received
Patient input summary sent for review to patient input groups March 07, 2018
Patient group comments on input summary closed March 14, 2018
Clarification:

- Patient input submission received
Submission received February 07, 2018
Submission accepted for review February 22, 2018
Review initiated February 23, 2018
Draft CDR review report(s) sent to applicant May 11, 2018
Comments from applicant on draft CDR review report(s) received May 23, 2018
Redaction requests from applicant on draft CDR review report(s) received May 30, 2018
CDR review team's comments on draft CDR review report(s) sent to applicant July 06, 2018
Canadian Drug Expert Committee (CDEC) meeting July 18, 2018
CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plans July 30, 2018
Embargo period ended and validation of redacted CDR review report(s) received August 14, 2018
CDEC Final Recommendation issued to applicant and drug plans August 21, 2018
CDEC Final Recommendation posted August 23, 2018
Final CDR review report(s) and patient input posted August 31, 2018
Last Updated : August 31, 2018

Pegfilgrastim

Details

Key Milestones2

Call for patient input postedDecember 14, 2017
Patient group input closedFebruary 09, 2018
Clarification:

- No patient input submission received

Submission receivedFebruary 23, 2018
Submission accepted for reviewMarch 02, 2018
Review initiatedMarch 05, 2018
Draft CDR review report(s) sent to applicantApril 19, 2018
Comments from applicant on draft CDR review report(s) receivedApril 24, 2018
Final CDR review report(s) sent to applicantApril 30, 2018
Final CDR review report(s) postedMay 08, 2018
Last Updated : November 6, 2019

nitisinone

Details

Key Milestones2
Call for patient input posted December 14, 2017
Patient group input closed February 09, 2018
Clarification:

- Patient input submission received
Patient input summary sent for review to patient input groups February 27, 2018
Patient group comments on input summary closed March 06, 2018
Clarification:

- Patient input summary feedback received
Submission received January 25, 2018
Submission accepted for review February 08, 2018
Review initiated February 09, 2018
Clarification:

- Temporary suspension due to non-payment of the application fee

- Temporary suspension of the review has been lifted
Draft CDR review report(s) sent to applicant May 31, 2018
Comments from applicant on draft CDR review report(s) received June 11, 2018
Redaction requests from applicant on draft CDR review report(s) received June 18, 2018
Clarification:

- No redactions requested by the applicant
CDR review team's comments on draft CDR review report(s) sent to applicant July 06, 2018
Canadian Drug Expert Committee (CDEC) meeting July 18, 2018
CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plans July 30, 2018
Embargo period ended and validation of redacted CDR review report(s) received August 14, 2018
CDEC Final Recommendation issued to applicant and drug plans August 21, 2018
CDEC Final Recommendation posted August 23, 2018
Final CDR review report(s) and patient input posted August 31, 2018
Last Updated : August 31, 2018

Erbitux for Left Sided Metastatic Colorectal Cancer – Details

Details

‡ Patient Advocacy Groups (or individual patients and caregivers when there is no patient group) and Clinicians who are registered with pCODR are eligible to provide Input and Feedback. Deadlines for Input and Feedback are by the end of the pCODR business day (5P.M. Eastern Time) of the date noted.

Last Updated : April 26, 2018

Alecensaro for Non-Small Cell Lung Cancer (first line) – Details

Details

‡ Patient Advocacy Groups (or individual patients and caregivers when there is no patient group) and Clinicians who are registered with pCODR are eligible to provide Input and Feedback. Deadlines for Input and Feedback are by the end of the pCODR business day (5P.M. Eastern Time) of the date noted.

Last Updated : August 13, 2018

Dolutegravir / rilpivirine

Details

Key Milestones2

Call for patient input postedNovember 23, 2017
Patient group input closedJanuary 19, 2018
Clarification:

- Patient input submission received

Patient input summary sent for review to patient input groupsJanuary 30, 2018
Patient group comments on input summary closedFebruary 06, 2018
Clarification:

- Patient input summary feedback received

Submission receivedDecember 21, 2017
Submission accepted for reviewJanuary 12, 2018
Review initiatedJanuary 15, 2018
Draft CDR review report(s) sent to applicantMarch 29, 2018
Comments from applicant on draft CDR review report(s) receivedApril 10, 2018
Redaction requests from applicant on draft CDR review report(s) receivedApril 17, 2018
CDR review team's comments on draft CDR review report(s) sent to applicantMay 04, 2018
Canadian Drug Expert Committee (CDEC) meetingMay 16, 2018
CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plansMay 30, 2018
Embargo period ended and validation of redacted CDR review report(s) receivedJune 13, 2018
CDEC Final Recommendation issued to applicant and drug plansJune 20, 2018
CDEC Final Recommendation postedJune 22, 2018
Final CDR review report(s) and patient input postedJune 22, 2018
Last Updated : June 22, 2018

Buprenorphine hydrochloride

Details

Key Milestones2
Call for patient input posted November 22, 2017
Patient group input closed January 18, 2018
Clarification:

- No patient input submission received
Submission received December 21, 2017
Submission accepted for review January 12, 2018
Review initiated January 15, 2018
Draft Canada's Drug Agency review report(s) sent to applicant April 03, 2018
Comments from applicant on draft Canada's Drug Agency review report(s) received April 12, 2018
Redaction requests from applicant on draft Canada's Drug Agency review report(s) received April 19, 2018
Clarification:

- No redactions requested by the applicant
Canada's Drug Agency review team's comments on draft Canada's Drug Agency review report(s) sent to applicant May 04, 2018
Canadian Drug Expert Committee (CDEC) meeting May 16, 2018
CDEC recommendation & redacted Canada's Drug Agency review report(s) sent to applicant and drug plans May 29, 2018
Embargo period ended and validation of redacted Canada's Drug Agency review report(s) received June 12, 2018
Clarification:

- Reconsideration requested
Applicant's request for reconsideration placed on CDEC agenda August 15, 2018
CDEC Final Recommendation issued to applicant and drug plans August 22, 2018
CDEC Final Recommendation posted August 24, 2018
Final Canada's Drug Agency review report(s) and patient input posted September 17, 2018
Last Updated : April 18, 2019