Professional Affairs and Stakeholder Engagement
To provide a focal point for advocacy, to enhance two-way communication and collaboration with healthcare professionals, patients, patient groups, and others on CDER issues concerning drug development, drug review, and drug safety.
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.
- 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 a project that involves both engagement and education teams is the development of the Drug Trials Snapshot webpages. 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.
- 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.