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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
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
The FDA warned a Chinese maker of active pharmaceutical ingredients over data integrity lapses and other serious deviations from current good manufacturing practice. Read More
Less than a year after the FDA said it would begin focusing on quality metrics, ISPE has released the first data from a quality metrics pilot program designed to give the agency better insight. Read More
The FDA should issue guidance officially adopting U.S. Pharmacopeia standards in its visual particle inspections of injectable drugs, law firm Hogan Lovells says in a Wednesday citizen petition submitted to the agency on behalf of an unnamed drugmaker. Read More
A New Jersey-based drug compounder and two of its top corporate officials have been indicted on fraud charges for repackaging and distributing unsterile drugs to several states. 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
Mylan is recalling two injectables — a hypertension drug and cancer treatment — due to quality control issues. Both drugs were manufactured in India. Read More
Some of the European Medicines Agency’s current recommendations on documenting quality standards for investigational medications will soon be out of date, as the Clinical Trials Regulation comes into effect next year. Read More