Sunday, September 26, 2010

CDER Ombudsman - BEST Person to complaint about FDA

This is who we all should complaint to

http://www.fda.gov/AboutFDA/CentersOffices/CDER/ContactCDER/CDEROmbudsman/default.htm

Copy from FDA site

CDER Ombudsman


The CDER Ombudsman, Virginia Behr, will be on extended leave September 1 until December 6, 2010. During that time, Captain Mary Kremzner will be the Acting CDER Ombudsman. You can contact her via email at mary.kremzner@fda.hhs.gov or cderombudsman@fda.hhs.gov or via telephone at 301-796-3144.
The CDER Ombudsman 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 advises CDER management about Center 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.
The Ombudsman makes every effort to respond to all complaints in a timely and effective manner. Upon request, communications with the Ombudsman will be considered confidential.
Mission/Vision
Mission: To quickly and impartially investigate complaints and resolve disputes between 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.     
Non-retaliation policy
The FDA Ombudsman page discusses FDA's position on retaliation.   

1 comment:

  1. Results are good, I know few who called and looks like we got FDAs attention now

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