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  1. CDER Contact Information

CDER Ombuds

Mission

To quickly and impartially look into 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 Ombuds receives questions and informally looks into complaints from CDER-regulated industry, law firms, health care practitioners, and consumers, and informally resolves disputes between those entities and CDER. These disputes can be of a regulatory, scientific, procedural, 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 Ombuds 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 ombuds standards of practice and core characteristics of federal ombuds, as laid out by the Administrative Conference of the United States (ACUS) in Recommendation 2016-5 – The Use of Ombuds in Federal Agencies. The core standards of practice are independence, confidentiality, and impartiality and the core characteristics include informality, a commitment to fairness, and a credible process.

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 Ombuds (Center level) is similar to the FDA Ombuds (Agency level), and both offices follow the same standards of practice and exhibit the core characteristics. However, utilizing the CDER Ombuds 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 Ombuds resides in the Center Director's Office of Executive Programs.

Non-Retaliation Policy

The FDA Ombuds page discusses FDA's position on retaliation.

Outreach

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

Ombuds Resources



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