In the past year, the Food and Drug Administration has built some momentum in speeding drug development and addressing product safety. Despite the progress made in improving its internal structure, the agency in the coming year will continue to face obstacles.
Last year, the Food and Drug Administration was busy issuing and launching more than two dozen guidances and initiatives. From stricter enforcement efforts to the formation of task forces to the issuance of new and updated guidelines, the agency made significant progress in modernizing the drug-approval process. The agency beefed up its efforts to improve the safety and effective use of prescription drugs and made strides in addressing the advances in science and medicine that are likely to lead to innovative therapies…
FDA Initiatives in 2006
Experts on this topic
Robert J. DeLuccia. President, CEO, and Vice Chairman of the Board, MacroChem Corp., Wellesley Hills, Mass.; MacroChem is a specialty pharmaceutical company that develops and seeks to commercialize products based on its proprietary drug-delivery technologies. For more information, visit macrochem.com.
Mario Ehlers, M.D., Ph.D. Chief Medical Officer, Pacific Biometrics Inc., Seattle; Pacific Biometrics specializes in central laboratory and contract research services to support pharmaceutical and diagnostic manufacturers. For more information, visit pacbio.com.
John Kamp. Executive Director, Coalition for Healthcare Communication, New York; The Coalition represents organizations dedicated to assuring the free exchange of scientific information. For more information, visit cohealthcom.org.
Douglass T. Simpson. President and CEO, Corgenix Medical Corp., Denver; Corgenix manufactures clinical laboratory diagnostic products. For more information, visit corgenixonline.com.