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Professional Affairs and Stakeholder Engagement

Professional Affairs and Stakeholder Engagement

Vision

To inspire and promote a culture of two-way engagement to enhance drug development and safety.


VISION STATEMENT

To inspire and promote a culture of two-way engagement to enhance drug development and safety.

MISSION

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.

CORE VALUES

People

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.

Accountability

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.

Stakeholder Focus

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

  • CDR Eleni Anagnostiadis, RPh, MPM, Director

 

Professional Affairs and Stakeholder Engagement teams:

  • The Drug Trials Snapshots Team - The Drug Trials Snapshots 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, age and ethnic groups. The information is available at the Drug Trials Snapshots website.
  • 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.

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. “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. 

 




Contact Us

Contact Point
Professional Affairs and Stakeholder Engagement
10903 New Hampshire Ave WO51-2341
Silver Spring, MD 20993-0002

Hours Available
CDERPASE@fda.hhs.gov
(301) 796-7600