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, review, 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.
Organization and Contacts
Professional Affairs and Stakeholder Engagement (PASE) will:
- Provide leadership and direction for developing, communicating, implementing, and assessing 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.
- Manage and coordinate preventable harm and/or safe medication use projects across the FDA, federal agencies, and other private and public sector stakeholders.
Professional Affairs and Stakeholder Engagement teams:
- Education Team - Develops research-based tools to inform and educate healthcare professionals and advocacy groups on issues that relate to regulatory activities of the Center.
An example of an education team project is the Drug Trials Snapshots. The Snapshots on these pages provide the public with information about participants in the clinical trials that supported the FDA approval of new molecular entities (NMEs) and original biologics approved after December 2014. Snapshots also include information on how clinical trials were designed and highlight differences in benefits and side effects among sex, race, and age groups.
Another example for the education team is the CDER Drug Approval Case Study, a “new learning tool designed to advance knowledge, insight and understanding of FDA’s drug regulatory processes.” This case study shows how a small pharmaceutical company reviews the path leading to FDA approval to market a new drug in the United States. This case study is meant to educate students and health professionals interested in drug development (including medical and pharmacy students), pharmaceutical and clinical innovators, small business staff as well as patients and patient advocacy groups.
- 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.
An example of an engagement team project is the public workshop that took place March 31, 2016.
PASE, in the FDA's Center for Drug Evaluation and Research (CDER), sponsored a public workshop entitled “Navigating CDER: What You Should Know for Effective Engagement.” The purpose of this public workshop was to help the public and patient advocacy groups gain a better understanding of how to effectively engage CDER.
Another example of engagement team interaction is this brief video explaining CDER’s drug approval process: “5 Things to Know About the New Drug Approval Process”
- Safe Use Team - 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.