WASHINGTON, D.C. – November 21, 2002 – The new commissioner of the U.S. Food and Drug Administration (FDA) says clinical research organizations (CROs) will play an important role in working with the FDA in continuing to enhance the development of new and effective medicines in the United States. Mark B. McClellan, M.D., Ph.D., spoke this week to the heads of 30 leading CROs at an event hosted by the Association of Clinical Research Organizations (ACRO).
"The FDA and drug developers face critical tasks in expediting the safe and careful development of a greater volume of increasingly complex potential therapies. To that end, the FDA will look for ways to improve communication with drug developers and thereby lower development costs," Dr. McClellan said. "In fulfilling our mission to protect the public, the agency is committed to science-based decision making, and to fostering the effective and ethical conduct of clinical trials."
Dr. McClellan said the FDA will look at innovative strategies and technologies to help reduce development time for new drug applications and enhance good manufacturing practices in order to get safe, critical products to market more quickly. "CROs hold great potential to help this process," McClellan said.
"Members of ACRO will give Dr. McClellan their full support in working with his agency to streamline safe and effective drug development," said Dennis Gillings, chairman of Quintiles Transnational Corp and ACRO. "We welcome his leadership in helping reshape processes for the development, review and approval of new drugs, biologics and medical devices."
The Association of Clinical Research Organizations fosters continued advancement of medical product development and expedites the introduction of new medicines and new treatments to improve health and save lives. Member companies provide a wide range of research and development services and assist pharmaceutical, biotechnology and medical device companies with the conduct of thousands of clinical trials each year. The founding member companies of ACRO are Covance Inc., Kendle International Inc., PAREXEL International Corp., PPD and Quintiles Transnational Corp. These companies employ more than 36,000 people worldwide and conduct research in 60 countries. For more information about ACRO, visit http://www.acrohealth.org/.