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FDA shows 'conservative' decision-making
14 Aug 2008
Regulatory Affairs
The US Food and Drug Administration (FDA) is being particularly cautious in its decisions on drug licence applications, according to an industry observer.
JP Morgan analyst Chris Schott said there is a "high level of FDA conservatism facing the pharma group", TheStreet.com reports.
According to the news source, he commented that around 50 per cent of drug applications made to the FDA over the past two years "have had a worse-than-expected outcome".
Furthermore, he stated that the trend is unlikely to change in the short term.
The website suggests that Merck's withdrawal of the formerly-popular Vioxx following links to heart problems had a significant impact on the whole of the pharmaceutical industry.
It argues that the FDA has been increasingly disinclined to approve any new drugs which may be linked to safety risks.
Merck and Schering-Plough announced in June the withdrawal of their new drug application formulation for the loratadine/montelukast combination tablet, having received a not-approvable letter in April from the FDA.
