Canada’s Drug Agency is launching a new 1-year learning period in our Scientific Advice program that will expand the type of guidance we offer to drug manufacturers to include those that are seeking advice after a “do not reimburse” recommendation is made for their product.
Procedural review: Canada’s Drug Agency (CDA-AMC) accepted a procedural review request, submitted by Sun Pharma Canada Inc., for the Canadian Drug Expert Committee (CDEC) final recommendation for clascoterone.
Status: Concluded.
| Call for patient/clinician input open | June 24, 2024 |
|---|---|
| Call for patient/clinician input closed | August 19, 2024 |
| Submission received | August 06, 2024 |
| Submission accepted | August 20, 2024 |
| Review initiated | August 21, 2024 |
| Draft CDA-AMC review report(s) provided to sponsor for comment | August 23, 2024 |
| Deadline for sponsors comments | August 30, 2024 |
| CDA-AMC review report(s) and responses to comments provided to sponsor | September 13, 2024 |
| Expert committee meeting (initial) | September 25, 2024 |
| Draft recommendation issued to sponsor | October 08, 2024 |
| Draft recommendation posted for stakeholder feedback | October 17, 2024 |
| End of feedback period | October 31, 2024 |
| Clarification: - Reconsideration: major revisions requested by sponsor | |
| Expert committee meeting | January 22, 2025 |
| Final recommendation issued to sponsor and drug plans | February 06, 2025 |
| Final recommendation posted | February 25, 2025 |
| Deadline for sponsor to submit redaction requests on draft CDA-AMC review report(s) | February 21, 2025 |
| CDA-AMC review report(s) posted | June 20, 2025 |
| Procedural Review accepted | April 14, 2025 |
| Procedural review concluded | June 19, 2025 |
| Clarification: - Final Recommendation upheld | |
| Milestones Title | Date |
|---|---|
| Call for patient/clinician/industry input open | 20-Jun-24 |
| Call for patient/clinician/industry input closed | 12-Aug-24 |
| Submission received | 19-Jun-24 |
| Review initiated | 20-Jun-24 |
| Expert committee meeting (initial) | 21-Nov-24 |
| Draft recommendation posted for stakeholder feedback | 12-Dec-24 |
| End of feedback period | 03-Jan-25 |
| Final recommendation posted | 04-Feb-25 |
| CADTH review report(s) posted | 29-Jan-25 |
| Call for patient/clinician input open | 19-Jun-24 |
|---|---|
| Call for patient/clinician input closed | 12-Aug-24 |
| Submission received | 28-Aug-24 |
| Submission accepted | 12-Sep-24 |
| Review initiated | 13-Sep-24 |
| Draft CADTH review report(s) provided to sponsor for comment | 29-Nov-24 |
| Deadline for sponsors comments | 10-Dec-24 |
| Clarification: - Submission temporarily suspended | |
| CDA-AMC review report(s) and responses to comments provided to sponsor | - |
| Expert committee meeting (initial) | - |
| Draft recommendation issued to sponsor | - |
| Draft recommendation posted for stakeholder feedback | - |
| End of feedback period | - |
Review Type: Rapid
| Call for patient/clinician input open | June 10, 2024 |
|---|---|
| Call for patient/clinician input closed | August 02, 2024 |
| Submission received | July 31, 2024 |
| Submission accepted | August 15, 2024 |
| Review initiated | August 16, 2024 |
| Draft CADTH review report(s) provided to sponsor for comment | November 01, 2024 |
| Deadline for sponsors comments | November 13, 2024 |
| CDA-AMC review report(s) and responses to comments provided to sponsor | December 06, 2024 |
| Expert committee meeting (initial) | December 18, 2024 |
| Draft recommendation issued to sponsor | - |
| Clarification: - CDEC recommendation held pending receipt of NOC and evaluation of the finalized submission requirements. | |
Review Type: Rapid
Provisional Funding Algorithm |
|
|---|---|
| Draft Report Posted: | 20-Jun-2024 |
| Stakeholder Feedback Deadline: | 27-Jun-2024 |
| Final Report Posted : | 01-Aug-2024 |
Review Type: Rapid
Provisional Funding Algorithm |
|
|---|---|
| Draft Report Posted: | 15-Aug-2024 |
| Stakeholder Feedback Deadline: | 22-Aug-2024 |
| Final Report Posted: | 9-Oct-2024 |
Rescheduled due to reconsideration of a reimbursement review file