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As of the end of fiscal 2015, postmarket requirements (PMR) were fulfilled for 69 percent of NDAs, marking a slight decline from the previous fiscal year. Read More
Indian drug regulators in seven states have accused 18 drugmakers of selling substandard therapies after quality tests identified a range of product issues ranging from deceptive labeling to inappropriate quantities of active ingredients. Read More
Drug sponsors hoping to submit an alternative postmarket report, known as the periodic benefit-risk evaluation report (PBRER), at a different frequency than required should plan to file a waiver request, the FDA said. Read More
The European Directorate for the Quality of Medicines and a number of foreign pharmaceutical authorities have agreed to improve information-sharing efforts and to strengthen collaboration. Read More
After the FDA clamped down on its facilities most of the year, Lupin has received clearance from the agency to produce drugs again at its site in Goa, India. Read More