News & Analysis on Clinical Trial Services & Contract Research And Development
The European CRO Federation is calling to widen the scope of a proposed delegated act related to pharmacovigilance legislation to include scenarios when observational PAES (post-authorisation efficacy studies) will be required.
DKSH says its contract extension with Bayer in Cambodia strengthens its position as a service provider for pharmaceutical companies throughout Southeast Asia.
Drug industry groups welcomed corporate tax cuts and increased research credits set out in the UK budget last night suggesting they are good news for manufacturers.
The PRACS Institute – the firm that emerged from the ashes of Cetero Research – has shut down operations at all locations according to local media reports.
The US FDA listed failure to ensure product sterility or explain why some batches were only partially released among criticisms of Apotex in a warning letter published this week.
Health Canada says moving to an electronic filing system for regulatory submissions will reduce costs but warned drugmakers not to include their credit card details.