FDA launches project to cut quality control lapses at drugmakers

By Toni Clarke WASHINGTON (Reuters) – The U.S. Food and Drug Administration launched an initiative on Monday aimed at reducing lapses in quality control at pharmaceutical manufacturing facilities. Dr. Janet Woodcock, head of the FDA’s pharmaceuticals division, said at a news conference that the project, some 10 years in the making, is designed to establish consistent quality standards for all drugs, whether brand name or generic. The FDA has established an Office of Pharmaceutical Quality that will be responsible for some 10,000 decisions a year and manage the process. …

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FDA launches project to cut quality control lapses at drugmakers