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U.S. Department of Health and Human Services

About FDA

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Professional Affairs and Stakeholder Engagement

Professional Affairs and Stakeholder Engagement logo

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:

  • 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
  • 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
  • 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



Contact FDA

(301) 796-7600
Professional Affairs and Stakeholders Engagement

10903 New Hampshire Avenue

Bldg. 51, Rm 2341

Silver Spring, MD 20993-0002