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More than a third of the applications the EMA received for central nervous system candidates raised concerns about efficacy that hindered approvals, an analysis shows. Read More
The FDA hit the Dongying Tiandong Pharmaceutical Co. with a warning letter for failing to investigate and document out-of-specification results when testing drug batches as well as GMP violations. Read More
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
The development process for biosimilar heparins no longer requires a comparative clinical trial, according to new guidance from the European Medicines Agency. 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