The Transparency Roadmap reflects the agency’s intention to maximize disclosure, guided by what is appropriate and good for public health. It was shaped by soliciting ideas and expertise from innovators across the agency, and it may continue to evolve as we seek the best ways to inform the public and protect public health while maintaining IP protections that cultivate a healthy innovation environment.
1. Complete Response Letters
2. Investigational Stage and Marketing Application Lifecycle Disclosures
3. New Approach Methodologies and Novel Biomarkers
4. Patient- and Consumer-Centered Product Labeling
5. Compliance and Inspectional Records