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

ulipristal acetate

Details

Key Milestones1
Call for patient input posted June 21, 2017
Patient group input closed July 26, 2017
Clarification:

- Patient input submission received
Patient input summary sent for review to patient input groups August 17, 2017
Patient group comments on input summary closed August 24, 2017
Clarification:

- Patient input summary feedback received
Request for Advice received June 21, 2017
Manufacturer informed of request for advice June 21, 2017
Manufacturer information or comments due July 06, 2017
Request for Advice initiated June 26, 2017
Draft CDR Request for Advice report sent to manufacturer August 30, 2017
Comments from manufacturer on draft CDR Request for Advice report received September 11, 2017
Redaction requests from manufacturer on draft CDR Request for Advice report received September 18, 2017
CDR review team's comments on draft CDR Request for Advice report sent to manufacturer October 05, 2017
Canadian Drug Expert Committee (CDEC) meeting October 18, 2017
CDEC recommendation & redacted CDR Request for Advice report sent to manufacturer and drug plans November 01, 2017
Embargo period ended and validation of redacted CDR Request for Advice report received November 15, 2017
Final CDR Request for Advice report and patient input posted December 15, 2017
Last Updated : November 6, 2019

Faslodex for Locally Advanced or Metastatic Breast 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 : February 16, 2018

Apomorphine

Details

Key Milestones2

Call for patient input postedJune 07, 2017
Patient group input closedJuly 27, 2017
Clarification:

- Patient input submission received

Patient input summary sent for review to patient input groupsAugust 08, 2017
Patient group comments on input summary closedAugust 14, 2017
Clarification:

- Patient input summary feedback received

Submission receivedJuly 06, 2017
Submission accepted for reviewJuly 20, 2017
Review initiatedJuly 21, 2017
Draft CDR review report(s) sent to applicantOctober 25, 2017
Comments from applicant on draft CDR review report(s) receivedNovember 03, 2017
Redaction requests from applicant on draft CDR review report(s) receivedNovember 10, 2017
CDR review team's comments on draft CDR review report(s) sent to applicantDecember 01, 2017
Canadian Drug Expert Committee (CDEC) meetingDecember 13, 2017
CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plansJanuary 02, 2018
Embargo period ended and validation of redacted CDR review report(s) receivedJanuary 16, 2018
CDEC Final Recommendation issued to applicant and drug plansJanuary 23, 2018
CDEC Final Recommendation postedJanuary 25, 2018
Final CDR review report(s) and patient input postedFebruary 06, 2018
Last Updated : April 18, 2018

Venclexta for Chronic Lymphocytic 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 : March 19, 2018

cysteamine bitartrate

Details

Key Milestones2
Call for patient input posted June 05, 2017
Patient group input closed July 25, 2017
Clarification:

- Patient input submission received
Patient input summary sent for review to patient input groups September 12, 2017
Patient group comments on input summary closed September 18, 2017
Clarification:

- Patient input summary feedback received
Submission received August 08, 2017
Submission accepted for review August 22, 2017
Review initiated August 23, 2017
Draft Canada's Drug Agency review report(s) sent to applicant November 07, 2017
Comments from applicant on draft Canada's Drug Agency review report(s) received November 16, 2017
Redaction requests from applicant on draft Canada's Drug Agency review report(s) received November 23, 2017
Canada's Drug Agency review team's comments on draft Canada's Drug Agency review report(s) sent to applicant December 01, 2017
Canadian Drug Expert Committee (CDEC) meeting December 13, 2017
CDEC recommendation & redacted Canada's Drug Agency review report(s) sent to applicant and drug plans January 03, 2018
Embargo period ended and validation of redacted Canada's Drug Agency review report(s) received January 17, 2018
CDEC Final Recommendation issued to applicant and drug plans January 24, 2018
CDEC Final Recommendation posted January 26, 2018
Final Canada's Drug Agency review report(s) and patient input posted February 08, 2018
Last Updated : May 8, 2019

nusinersen

Details

Request for Resubmission: Eligible (Decision Date: May 24, 2018)

Key Milestones2
Call for patient input posted June 01, 2017
Patient group input closed July 21, 2017
Clarification:

- Patient input submission received
Patient input summary sent for review to patient input groups July 27, 2017
Patient group comments on input summary closed August 04, 2017
Clarification:

- Patient input summary feedback received
Submission received June 28, 2017
Submission accepted July 13, 2017
Review initiated July 14, 2017
Draft Canada's Drug Agency review report(s) sent to sponsor October 02, 2017
Comments from sponsor on draft Canada's Drug Agency review report(s) received October 12, 2017
Redaction requests from sponsor on draft Canada's Drug Agency review report(s) received October 19, 2017
Canada's Drug Agency review team's comments on draft Canada's Drug Agency review report(s) sent to sponsor November 03, 2017
Canadian Drug Expert Committee (CDEC) meeting November 15, 2017
CDEC recommendation & redacted Canada's Drug Agency review report(s) sent to sponsor and drug plans November 29, 2017
Embargo period ended and validation of redacted Canada's Drug Agency review report(s) received December 13, 2017
CDEC Final Recommendation issued to sponsor and drug plans December 20, 2017
CDEC Final Recommendation posted December 22, 2017
Final Canada's Drug Agency review report(s) and patient input posted January 10, 2018
Last Updated : June 12, 2020

fluticasone furoate/vilanterol

Details

Key Milestones2

Call for patient input postedMay 31, 2017
Patient group input closedJuly 20, 2017
Clarification:

- Patient input submission received

Patient input summary sent for review to patient input groupsJuly 25, 2017
Patient group comments on input summary closedAugust 01, 2017
Clarification:

- Patient input summary feedback received

Submission receivedJune 28, 2017
Submission acceptedJuly 13, 2017
Review initiatedJuly 14, 2017
Draft Canada's Drug Agency review report(s) sent to sponsorSeptember 28, 2017
Comments from sponsor on draft Canada's Drug Agency review report(s) receivedOctober 10, 2017
Redaction requests from sponsor on draft Canada's Drug Agency review report(s) receivedOctober 17, 2017
Canada's Drug Agency review team's comments on draft Canada's Drug Agency review report(s) sent to sponsorNovember 03, 2017
Clarification:

- Voluntarily withdrawn by the manufacturer on 2017-Nov-09

Last Updated : June 18, 2020

Pembrolizumab (Keytruda) classical Hodgkin Lymphoma – 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 : January 22, 2018

cyclosporine

Details

Key Milestones2

Call for patient input postedApril 17, 2017
Patient group input closedJune 06, 2017
Clarification:

- Patient input submission received

Patient input summary sent for review to patient input groupsJune 26, 2017
Patient group comments on input summary closedJuly 04, 2017
Clarification:

- Patient input summary feedback received

Submission receivedMay 15, 2017
Submission accepted for reviewMay 30, 2017
Review initiatedMay 31, 2017
Clarification:

- Voluntarily withdrawn by the manufacturer on 2017-July-11

Last Updated : March 22, 2019