An NHS England spokesperson confirmed Feb. 18 that the agency will investigate whether more than 130 NHS staff involved in assessing drugs were also paid as consultants by drugmakers. Source:…
Drugmakers submitting anonymized clinical data in applications to the EMA must keep up on technology advances that could put that data at risk for re-identification. Source: International Pharmaceutical Regulatory Monitor
The FDA has slammed yet another Indian drugmaker for data integrity issues. This time it rebuked Ipca Laboratories for data falsification at three of the company’s manufacturing facilities. Source: International…
The European Medicines Agency and the European Commission published new track-and-trace safety requirements Feb. 10 affecting all drugmakers doing business in EU countries. Source: International Pharmaceutical Regulatory Monitor