Last Updated : September 27, 2017
Details
Key Milestones2 |
|
|---|---|
| Call for patient input posted | September 26, 2017 |
| Patient group input closed | November 15, 2017 |
| Clarification:
- No patient input submission received |
|
| Submission received | October 25, 2017 |
| Submission accepted for review | November 08, 2017 |
| Review initiated | November 09, 2017 |
| Draft CDR review report(s) sent to applicant | February 01, 2018 |
| Comments from applicant on draft CDR review report(s) received | February 12, 2018 |
| Redaction requests from applicant on draft CDR review report(s) received | February 20, 2018 |
| CDR review team's comments on draft CDR review report(s) sent to applicant | March 09, 2018 |
| Canadian Drug Expert Committee (CDEC) meeting | March 21, 2018 |
| CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plans | April 03, 2018 |
| Embargo period ended and validation of redacted CDR review report(s) received | April 17, 2018 |
| CDEC Final Recommendation issued to applicant and drug plans | April 24, 2018 |
| CDEC Final Recommendation posted | April 27, 2018 |
| Final CDR review report(s) and patient input posted | May 17, 2018 |
Last Updated : May 17, 2018
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 : May 3, 2018
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 : May 3, 2018
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 6, 2018
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 25, 2018
Details
Key Milestones2 |
|
|---|---|
| Call for patient input posted | August 31, 2017 |
| Patient group input closed | October 23, 2017 |
| Clarification:
- Patient input submission received |
|
| Submission received | September 29, 2017 |
| Submission accepted for review | October 16, 2017 |
| Review initiated | October 20, 2017 |
| Draft CDR review report(s) sent to applicant | January 24, 2018 |
| Comments from applicant on draft CDR review report(s) received | February 02, 2018 |
| Redaction requests from applicant on draft CDR review report(s) received | February 09, 2018 |
| Canadian Drug Expert Committee (CDEC) meeting | March 21, 2018 |
| CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plans | April 04, 2018 |
| Embargo period ended and validation of redacted CDR review report(s) received | April 18, 2018 |
| CDEC Final Recommendation issued to applicant and drug plans | April 25, 2018 |
| CDEC Final Recommendation posted | April 27, 2018 |
| Final CDR review report(s) and patient input posted | April 27, 2018 |
Last Updated : January 14, 2019
Details
Key Milestones2 |
|
|---|---|
| Call for patient input posted | August 30, 2017 |
| Patient group input closed | October 20, 2017 |
| Clarification:
- Patient input submission received |
|
| Patient input summary sent for review to patient input groups | November 02, 2017 |
| Patient group comments on input summary closed | November 09, 2017 |
| Clarification:
- Patient input summary feedback received |
|
| Submission received | September 28, 2017 |
| Submission accepted for review | October 13, 2017 |
| Review initiated | October 16, 2017 |
| Draft CDR review report(s) sent to applicant | January 04, 2018 |
| Comments from applicant on draft CDR review report(s) received | January 15, 2018 |
| Redaction requests from applicant on draft CDR review report(s) received | January 22, 2018 |
| CDR review team's comments on draft CDR review report(s) sent to applicant | February 08, 2018 |
| Canadian Drug Expert Committee (CDEC) meeting | February 21, 2018 |
| CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plans | March 05, 2018 |
| Embargo period ended and validation of redacted CDR review report(s) received | March 19, 2018 |
| CDEC Final Recommendation issued to applicant and drug plans | March 26, 2018 |
| CDEC Final Recommendation posted | March 28, 2018 |
| Final CDR review report(s) and patient input posted | April 24, 2018 |
Last Updated : April 30, 2018
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 : May 22, 2018
Details
Key Milestones2 |
|
|---|---|
| Call for patient input posted | August 25, 2017 |
| Patient group input closed | October 17, 2017 |
| Clarification:
- Patient input submission received |
|
| Patient input summary sent for review to patient input groups | October 24, 2017 |
| Patient group comments on input summary closed | October 31, 2017 |
| Clarification:
- Patient input summary feedback received |
|
| Submission received | September 26, 2017 |
| Submission accepted for review | October 13, 2017 |
| Clarification:
- Submission was not accepted for review on 2017 Oct 11 - Revised category 1 requirements received on 2017 Oct 13 |
|
| Review initiated | October 16, 2017 |
| Draft CDR review report(s) sent to applicant | January 05, 2018 |
| Comments from applicant on draft CDR review report(s) received | January 16, 2018 |
| Redaction requests from applicant on draft CDR review report(s) received | January 23, 2018 |
| CDR review team's comments on draft CDR review report(s) sent to applicant | February 08, 2018 |
| Canadian Drug Expert Committee (CDEC) meeting | February 21, 2018 |
| CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plans | March 06, 2018 |
| Embargo period ended and validation of redacted CDR review report(s) received | April 18, 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 | October 17, 2018 |
| CDEC Final Recommendation issued to applicant and drug plans | October 24, 2018 |
| CDEC Final Recommendation posted | October 26, 2018 |
| Final CDR review report(s) and patient input posted | November 08, 2018 |
Last Updated : December 21, 2018