Professional Affairs and Stakeholder Engagement
To inspire and promote a culture of two-way engagement to enhance drug development and safety.
To improve our stakeholder’s drug regulatory insight and understanding.
To enrich the experience of patients, advocacy groups, health care professionals, and agencies in engaging with CDER.
To provide a focal point for advocacy and two-way engagement on drug development, and safety.
To enhance safe use of medications and reduce preventable harm from medication misuse, abuse, and errors.
Our people are the foundation of our organization. We foster diversity, professionalism, and compassion. We treat each other with dignity, equality, and work as a team to reach common goals.
We are responsible for the success of engagement activities with our internal and external stakeholders, and for our decisions and actions.
Strategic Collaboration and Innovation
We engage in proactive two way collaboration and cooperative working relationships with our internal and external partners. We apply new concepts, innovative ideas, and creative approaches to foster positive change to meet the challenges of the future.
Ethical Standards and Transparency
We value integrity, a culture of inclusion and trust, open honest communication, and respect for all points of view.
We are passionate in serving our stakeholders to protect, promote, and advance public health.
Professional Affairs and Stakeholder Engagement (PASE) will:
- Provide leadership and direction for developing, assessing, communicating, and implementing an advocacy and stakeholder relations strategy for CDER.
- Conduct research to ensure that CDER has a thorough understanding of partner, stakeholder, and public opinion about issues of interest to CDER.
- Collaborate and support the public and private sector within the healthcare community to improve the safe use of over-the-counter and prescription medications.
Organization and Contacts
- Engagement Team - Provides systematic and coordinated engagement with stakeholders to develop complementary, collaborative actions that will improve medication use and increase awareness of regulatory activities. This includes meeting with and responding to advocacy groups and professional organizations about drug development, drug review, and drug safety.
- Submit your request for a meeting on drug-related topics
- The engagement team hosts public workshops to help the public and patient advocacy groups gain a better understanding of how to effectively engage with CDER.
- This brief video, produced by the Engagement Team, explains CDER’s drug approval process.Submit your request for a meeting on drug-related topics.
5 Things to Know About the New Drug Approval Process
- Safe Use Initiative - Collaborates, plans, and manages non-regulatory initiatives to make significant improvements in the safe use of medications and reduce preventable harm from medication misuse, abuse, and errors. Safe Use projects are described on the Safe Use Initiative webpages.
- Professional Affairs and Stakeholder Engagement
- 10903 New Hampshire Ave WO51-2341
Silver Spring, MD 20993-0002
- (301) 796-7600