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The House plans to vote Wednesday on a new version of its 21st Century Cures legislation, nearly a year-and-a-half after it passed its first version. Read More
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
The European Medicines Agency adopted a final guideline setting out the information required for the evaluation of active chemical substances used in drug products. Read More
With just three work weeks left in its lame duck session, many are expecting the Senate to vote on its 21st Century Cures legislation package. Read More
As a precursor to the FDA’s official implementation of a quality metrics reporting program, the agency will begin accepting voluntary data submissions from drugmakers on the quality of their finished dosage form drugs and APIs in early 2018 for a pilot run of the risk-based system. Read More