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 providers, and consumers by offering an informal, confidential, and neutral environment.

Vision: To improve the functionality and transparency of CDER by providing efficient resolution of disputes and by fostering communications with stakeholders.     

The CDER Ombudsman (aka Ombuds) receives and investigates complaints from CDER-regulated industry, law firms, health care providers, and consumers, and informally resolves disputes between those entities and CDER. The Ombudsman also receives internal and external feedback about CDER’s programs and overall performance and advises Center management about program issues. Also, the Ombudsman can assist with resolution of scientific differences of opinion amongst CDER staff. 

The Ombudsman performs these duties while adhering to the ombudsman principles of ensuring 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.