Last Updated : January 26, 2016
We recommend that you review the general information on our Scientific Advice Program, including the Scientific Advice process, prior to submitting your application. You may also want to review the following guidance and templates for use during the process:
In addition, our Frequently Asked Questions may help you with any questions or concerns you may have.
An application to the Scientific Advice Program constitutes the applicant's agreement with the Program policies, guidelines, and processes, as described on the Scientific Advice website. As part of your application, you will be required to declare that your company is aware of and agrees to the following:
You will also be asked to indicate the permissions, if any, that your company grants in order for us to share company information and information produced through the Scientific Advice Program with patient representatives involved in the Program.
Click here for more information on patient involvement in the Scientific Advice Program.
Complete and submit the online application form.
You will be required to provide specific information about your drug on the application form. You may want to review the application form ahead of time to ensure that you have collected all the information required.
Some notes about the online application form:
Our Scientific Advice staff will contact you within ten (10) business days of receipt of your application to confirm the eligibility of your product, set a time period for the Scientific Advice meeting, discuss next steps, and answer any questions you may have.