Letter to the FDA Opposing Resumption of Clinical Trials Testing Anti-Nerve Growth Factor Drugs
April 16, 2012
The Food and Drug Administration (FDA) should reject the recommendation of the Arthritis Advisory Committee to resume clinical development of anti-nerve growth factor drugs for management of chronic pain. Further human studies of these drugs would be unethical and not approvable under FDA regulations for the protection of human subjects because the risks outweigh the potential benefits to subjects and the importance of the knowledge that is expected to result.
View letter as PDF
May 7, 2012 Food and Drug Administration (FDA) response to our April 16, 2012 letter