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U.S. Department of Health and Human Services

About FDA

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CDER Ombudsman

Mission: To quickly and impartially investigate complaints and resolve disputes between the Center for Drug Evaluation and Research (CDER) and CDER-regulated industry, health care practitioners, and consumers by offering an informal, confidential, and neutral environment.

Vision: To improve CDER’s operations and enhance transparency by providing efficient resolution of disputes and by fostering communication with stakeholders.     

The CDER Ombudsman (aka Ombuds) receives questions and investigates complaints from CDER-regulated industry, law firms, health care providers, and consumers, and informally resolves disputes between those entities and CDER. These disputes can be of a regulatory, scientific, or administrative nature. The Ombuds serves as a one-stop-shop for quick and informal advice or referrals, whatever the question or problem might be. Also, the Ombudsman receives feedback about CDER’s programs and overall performance, advises Center management about program issues, and can assist with resolution of scientific differences of opinion among CDER staff. 

The Ombuds performs these duties while adhering to the ombudsman principles of confidentiality, neutrality, and informality. Every effort is made to respond to all complaints in a timely and effective manner. Upon request, communication with the Ombuds will be considered confidential.

The role of the CDER Ombudsman (Center level) is similar to the FDA Ombudsman (Agency level), and both offices follow the same operating principles of confidentiality, informality, and neutrality. However, utilizing the CDER Ombudsman provides a way for anyone with a complaint or dispute involving CDER entities or programs to work through their problem at a level closer to the source. The CDER Ombudsman’s Office is in the Center Director's Office of Executive Programs. 

Non-Retaliation Policy
The FDA Ombudsman page discusses FDA's position on retaliation.

Outreach
The CDER ombudsman will consider requests for participation in outreach activities such as webinars, presentations, panel discussions, and so on. Please send your request to Virginia.Behr@fda.hhs.gov.

 

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