Published in Medical Letter on the CDC and FDA, January 2nd, 2005
The FDA's clearance to proceed with a phase I safety trial came following the agency's completed review of the study's clinical design and the unanimous vote of the Recombinant DNA Advisory Committee on March 15, 2004, that the first human clinical study of Oragenics' Replacement Therapy be carried out under the protocol proposed by the company. The FDA had placed Oragenics' original investigational new drug application on clinical hold in May 2003, pending further review of the...
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