Scientific Advice Application

Step 1: Review the Process and Templates

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.

Step 2: Read the Details

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.

Step 3: Submit Online Application Form

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:

  • You must apply at least 18 weeks in advance of your preferred Scientific Advice meeting time period; you are encouraged to apply more than 18 weeks in advance in order to reserve your preferred meeting time period.
  • In selecting a time period for your Scientific Advice meeting, consider that your Briefing Book is due 14 weeks before the Scientific Advice meeting.
  • The date proposed for the Scientific Advice meeting that you indicate in the application does not guarantee that it is available for booking. Please contact [email protected] to discuss the availability of time periods for meetings.

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.