肇庆市机动车驾驶培训教练员教学质.pptVIP

Anti-Infective Drug Products and Drug Safety and Risk ManagementAdvisory Committees Meeting December 14 15, 2006 Edward Cox, MD MPH Acting Director, Office of Antimicrobial Products OND/CDER/ FDA Welcome Welcome Topic for discussion NDA 21-144 Ketek? (telithromycin) Tablets Overall benefits and risks based upon what we know today Information in the original NDA the additional information that we have since the drugs was approved in April 2004 Primary purpose of the meeting To seek the Advisory Committee’s advice on the overall assessment of risks and benefits of Ketek for each of its app