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ISPE’s quality metrics team has narrowed from 16 to five the number of metrics it will ask drugmakers to collect data on during phase two of a pilot program aimed at helping the FDA boost quality compliance. Read More
The FDA is offering two grants of up to $600,000 each over three years in exchange for data to establish statistically based pharmaceutical quality standards — a further sign of the agency’s commitment to using quality metrics. Read More
Particulates continue to be a major cause of recalled injectables, with Mylan on April 23 recalling eight lots of four drugs after foreign matter was found during quality control tests. Read More
European regulators are looking to industry for suggestions on the best ways to get generic versions of topical drugs approved without having to conduct time-consuming and expensive clinical trials to prove bioequivalence. Read More
Beleaguered Indian generics maker Wockhardt said Tuesday it will recall all remaining batches of 12 to 15 products from the U.S. that were manufactured at its Waluj and Chikalthana, India, plants, due to quality concerns. Read More
Particulates continue to be a major cause of recalled injectables, with Mylan on Thursday recalling eight lots of four drugs after foreign matter was found during quality control tests. Read More
Reckitt Benckiser is voluntarily recalling 1.5 million units of four varieties of its Mucinex liquid cold medicines nationwide because the back labels may not show they contain acetaminophen and other active ingredients. Read More
The World Health Organization has launched VigiAccess, a database that allows users to view information on suspected adverse drug reactions collected by national drug authorities in more than 110 countries and spanning more than 100,000 products. Read More