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  • Regulatory NewsRegulatory News

    Best of 2017: What Readers Clicked on This Year

    From Trump to biosimilars to a new digital health pilot run by the US Food and Drug Administration (FDA), here are the top 10 most-read articles of 2017, with some updates on what has occurred since the stories were published. 10. EMA to Suspend More Than 300 Drugs due to Unreliable CRO Studies Back in March, the European Medicines Agency (EMA) recommended the suspension of more than 300 approvals and applications for generic drugs for which bioequivalence studies w...
  • Regulatory NewsRegulatory News

    FDA Warns Indian Contract Manufacturer Hetero Labs

    The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent earlier this month to India-based contract manufacturer Hetero Labs’ manufacturing site on the outskirts of Hyderabad for significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. The inspection from December 2016 found the firm failed to properly investigate process deviations and out-of-specification (OOS) laboratory results, ma...
  • Regulatory NewsRegulatory News

    EC Report Calls for New Network of Reference Labs for Human Pathogens

    The European Commission is calling for a formally defined EU-wide system for reference laboratory networks for human pathogens as the benefits are likely to outweigh the costs, according to an analysis of such a system released on Friday. Currently, many national reference labs for human pathogens have a hard time responding in a coordinated manner to new and emerging infectious threats. The aim of an EU-wide network would be to better respond to cross-border threats, a...
  • Regulatory NewsRegulatory News

    Novartis Subsidiary Pays $16m to Settle Charges of Illegally Shipping Drugs and Devices to Iran, Syria and Sudan

    Novartis subsidiary Alcon Laboratories has agreed to pay more than $16 million to settle allegations of manufacturing drugs and medical devices in the US and then shipping them to Iran, Syria and Sudan despite US trade embargoes that prohibit such sales. According to the settlement agreement with the US Department of Commerce, Texas-based Alcon Labs and Switzerland-based Alcon Pharmaceuticals sent at least 100 shipments of devices and medical equipment worth more than $8...
  • Regulatory NewsRegulatory News

    NIH’s Exclusive Licenses to Biotech, Pharma Start-Ups: Lots of Secrecy, Few Successes

    It’s well-known that the National Institutes of Health (NIH) offers billions of dollars in grants to US academic research facilities. What’s less well-known is that each year, hundreds of new inventions are produced in the laboratories of NIH, the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA), and these inventions are licensed out to private companies in the US and internationally for further research and development, with the...