Pharmaceutical Reviews Update — Issue 51

Program Updates 

1. Update to Ethics Review Component of Complex Reviews

The description of the Ethics Review for Complex Reviews has been updated to further clarify the domains of ethical considerations explored within each review and the use of summary reports where appropriate. The linked Ethics Review Report template has been removed to reflect a customized approach to the reporting of ethical considerations based on the complexity of ethical issues present.

2. New Flexible Service Through Our Scientific Advice Program

Drug sponsors can now request a flexible service through our Scientific Advice program that can include a shorter time frame.

For Scientific Advice after pivotal trials designs are finalized, the program now offers more timely advice on anticipated key uncertainties or evidence gaps based on the clinical evidence plan. This flexible service can be completed with a lower fee in as little as 4 weeks.  

In addition, the Standard Scientific Advice process is still available before and after pivotal trial protocols are finalized. Sponsors may request a flexible service for the standard process, in as short as 8 weeks instead of the standard 14 weeks between the Briefing Book submission and Scientific Advice meeting dates. Standard fees ranges for this service will apply.    

Please contact us for more information at [email protected]. We are happy to work with you to customize the offering to best meet your needs.