In 2014, the FDA Center for Drug Evaluation and Research approved the most drugs since 1996. The FDA approved 41 novel medications last year, 62% more than the 27 approved in 2013. The only year that topped 2014 was 1996, when 53 new drugs were approved.
The new drug approvals consisted mostly of innovative, expensive treatments where competition is limited and costs of treatment can often exceed $100,000 per patient per year. Infectious ...
continue reading...The European Medicines Agency has announced it’s investigating reports that Swiss drug maker Roche AG failed to properly report about 80,000 reports of possible side effects in the U.S.
According to a report on Medical Xpress, European regulators spotted the problems during a routine inspection. The inspectors found that Roche had not properly analyzed the accounts of possible side effects to see if they were truly suspected adverse events that needed to be officially reported.
The reports included many different types of ...
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