Improving Manufacturing Science Is Key, According to CDER Report
The US Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) yesterday issued its 2004 report to the nation, citing the center’s key initiatives: improving the science of drug manufacturing, streamlining the path for developing new drugs, and improving methods for identifying and analyzing drug safety issues.
The report says that the center’s overhaul of the pharmaceutical good manufacturing practices “encourages manufacturers to modernize their methods, equipment, and facilities to eliminate both production inefficiencies and undue risks for consumers.” It also says the risk-based approach to inspections makes “better use of limited resources.”
The 66-page report, Improving Public Health through Human Drugs, says CDER developed initiatives to improve drug safety, protect against bioterrorism, and accelerate drug development while maintaining its performance in reviewing new drugs and overseeing the safety of marketed drugs. During 2004, CDER approved 119 new medicines and 380 generic versions of existing drugs, and evaluated more than 400,000 reports of adverse drug events, including more than 20,000 submitted directly by individuals.