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The FDA has handed Hospira its seventh warning letter in seven years and the second in the past six months, this time for poor sterile processing, inadequate batch failure investigations and data integrity weaknesses at its Liscate, Italy, manufacturing plant. Read More
The FDA’s Office of Pharmaceutical Quality is developing a new inspection protocol that will focus on expert investigator-developed questions and assessment practices. Read More
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