Scientific Advice Application Form

1. Information about the Applicant

2. Product Description

Type of drug product

3. Stage of Development

To be eligible for our Scientific Advice, a drug product must be in early stage development at a point where changes in development plans based on Scientific Advice are still possible.

4. Purpose of Application

5.  Scientific Advice Process

6. Proposed Scientific Advice Meeting

Please contact us in advance to confirm preferred meeting availabilities.

7. Briefing Book Content

8. Declaration for the Scientific Advice Program at CDA-AMC

9. Permission to Share Information With Patient Representatives

Patient involvement is part of the Scientific Advice process for every application; however, confidential information from the applicant will be shared with patient representative(s) only with permission of the applicant, as provided below.

10. Person Providing Authorized Consent

Name and title of person providing authorized consent on behalf of the applicant. Providing your name here indicates that you have authority to bind the applicant.