Last Updated : September 30, 2020
The Standard Scientific Advice timeline is outlined in the table that follows. Please note that sponsors may request customization of timelines for Scientific Advice with Canada’s Drug Agency.a Customization may include shortened timelines, as soon as 8 weeks and up to 14 weeks, between the Briefing Book submission and the Scientific Advice meeting.a This may not be feasible with Parallel Scientific Advice
Standard timeline |
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| 1 | Submit application 4 weeks before the Briefing Book |
1. Application 1.1 Submit online application 4 weeks before the Briefing Book submission. 1.2 The application is assessed for eligibility. 1.3 If eligible, the applicant receives confirmation of acceptance and the first invoice. |
| 2 | Submit Briefing Book 14 weeks before the Scientific Advice meeting |
2. Briefing Book 2.1 Submit Briefing Book 14 weeks before the Scientific Advice meeting 2.2 The applicant receives the Briefing Book clarification questions. 2.3 The applicant receives the second invoice. |
| 3 | Attend Scientific Advice meeting |
3. Scientific Advice meeting This is a 3-hour meeting where CDA-AMC discusses the advice with the applicant based on the questions submitted in the Briefing Book. This meeting is held virtually, unless otherwise requested. |
| 4 | Receive record of Scientific Advice 4 weeks after the Scientific Advice meeting |
4. Record of Scientific Advice (ROSA) 4.1 The applicant receives the written ROSA 4 weeks after the Scientific Advice meeting. 4.2 The applicant submits ROSA clarification questions (optional). 4.3 The applicant receives the final invoice. |
Please contact [email protected] for more information or if you require customized timelines.
Refer to the Scientific Advice process for more information.
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Last Updated : September 30, 2020