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

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

fluocinolone acetonide

Details

Key Milestones2

Call for patient input postedNovember 22, 2017
Patient group input closedJanuary 18, 2018
Clarification:

- No patient input submission received

Submission receivedDecember 21, 2017
Submission accepted for reviewJanuary 12, 2018
Review initiatedJanuary 15, 2018
Clarification:

- Voluntarily withdrawn by the manufacturer on 2018-Mar-23

Last Updated : March 26, 2018

Tecentriq for Non-Small Cell Lung 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 : July 6, 2018

netupitant / palonosetron

Details

Key Milestones2
Call for patient input posted November 16, 2017
Patient group input closed January 12, 2018
Clarification:

- No patient input submission received
Submission received December 08, 2017
Submission accepted for review December 22, 2017
Review initiated January 02, 2018
Draft CDR review report(s) sent to applicant March 16, 2018
Comments from applicant on draft CDR review report(s) received March 27, 2018
Redaction requests from applicant on draft CDR review report(s) received April 04, 2018
Clarification:

- No redactions requested by the applicant
CDR review team's comments on draft CDR review report(s) sent to applicant May 04, 2018
Canadian Drug Expert Committee (CDEC) meeting May 16, 2018
CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plans May 30, 2018
Embargo period ended and validation of redacted CDR review report(s) received June 13, 2018
CDEC Final Recommendation issued to applicant and drug plans June 20, 2018
CDEC Final Recommendation posted June 22, 2018
Final CDR review report(s) and patient input posted June 22, 2018
Last Updated : June 22, 2018

brodalumab

Details

Key Milestones2

Call for patient input postedNovember 08, 2017
Patient group input closedJanuary 04, 2018

Clarification:

- Patient input submission received

Patient input summary sent for review to patient input groupsJanuary 11, 2018
Patient group comments on input summary closedJanuary 18, 2018

Clarification:

- Patient input summary feedback received

Submission receivedDecember 14, 2017
Submission accepted for reviewJanuary 05, 2018
Review initiatedJanuary 08, 2018
Draft CDR review report(s) sent to applicantMarch 22, 2018
Comments from applicant on draft CDR review report(s) receivedApril 03, 2018
Redaction requests from applicant on draft CDR review report(s) receivedApril 10, 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 postedJuly 16, 2018
Last Updated : July 16, 2018

letermovir

Details

Key Milestones2

Call for patient input postedNovember 03, 2017
Patient group input closedDecember 22, 2017
Clarification:

- Patient input submission received

Patient input summary sent for review to patient input groupsJanuary 10, 2018
Patient group comments on input summary closedJanuary 17, 2018
Clarification:

- Patient input summary feedback received

Submission receivedDecember 07, 2017
Submission accepted for reviewDecember 21, 2017
Review initiatedDecember 22, 2017
Draft CDR review report(s) sent to applicantMarch 15, 2018
Comments from applicant on draft CDR review report(s) receivedMarch 26, 2018
Redaction requests from applicant on draft CDR review report(s) receivedApril 03, 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 postedJuly 09, 2018
Last Updated : July 9, 2018

Besponsa for Acute Lymphoblastic Leukemia – 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 : July 23, 2018

Lonsurf for 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 : July 23, 2018

sebelipase alfa

Details

Key Milestones2
Call for patient input posted October 04, 2017
Patient group input closed November 23, 2017
Clarification:

- Patient input submission received
Patient input summary sent for review to patient input groups December 04, 2017
Patient group comments on input summary closed December 11, 2017
Clarification:

- Patient input summary feedback received
Submission received November 02, 2017
Submission accepted for review November 16, 2017
Review initiated November 17, 2017
Draft CDR review report(s) sent to applicant February 16, 2018
Comments from applicant on draft CDR review report(s) received March 02, 2018
Clarification:

- Extension request received from applicant

- Extension granted
Redaction requests from applicant on draft CDR review report(s) received March 09, 2018
CDR review team's comments on draft CDR review report(s) sent to applicant March 29, 2018
Canadian Drug Expert Committee (CDEC) meeting April 11, 2018
CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plans April 25, 2018
Embargo period ended and validation of redacted CDR review report(s) received June 07, 2018
Clarification:

- Request for extension to embargo period received from the manufacturer

- Embargo extension request granted

- Reconsideration requested
Applicant's request for reconsideration placed on CDEC agenda September 19, 2018
CDEC Final Recommendation issued to applicant and drug plans September 26, 2018
CDEC Final Recommendation posted September 28, 2018
Final CDR review report(s) and patient input posted November 21, 2018
Last Updated : December 21, 2018

ocrelizumab

Details

Key Milestones2

Call for patient input postedSeptember 27, 2017
Patient group input closedNovember 16, 2017
Clarification:

- Patient input submission received

Patient input summary sent for review to patient input groupsNovember 22, 2017
Patient group comments on input summary closedNovember 29, 2017
Clarification:

- Patient input summary feedback received

Submission receivedOctober 26, 2017
Submission accepted for reviewNovember 09, 2017
Review initiatedNovember 10, 2017
Draft CDR review report(s) sent to applicantFebruary 05, 2018
Comments from applicant on draft CDR review report(s) receivedFebruary 14, 2018
Redaction requests from applicant on draft CDR review report(s) receivedFebruary 22, 2018
CDR review team's comments on draft CDR review report(s) sent to applicantMarch 09, 2018
Canadian Drug Expert Committee (CDEC) meetingMarch 21, 2018
CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plansApril 05, 2018
Embargo period ended and validation of redacted CDR review report(s) receivedApril 19, 2018
CDEC Final Recommendation issued to applicant and drug plansApril 26, 2018
CDEC Final Recommendation postedApril 30, 2018
Final CDR review report(s) and patient input postedMay 08, 2018
Last Updated : May 10, 2018