Her areas of expertise include the cutting-edge early market access schemes that are being trialed around the world for taking drugs and medical devices to market faster. She is also interested in initiatives for harmonizing regulations at the global level as well as issues affecting clinical trials, manufacturing and post-market safety monitoring. She explores the challenges and opportunities that these issues introduce for both industry and the regulators and is on a constant look out for what might be coming next.
A scientist by training, Neena started her journalistic career at Informa in 1997. She has been the deputy editor of Scrip Regulatory Affairs since 2007. Prior to that, she worked as the science editor for Clinica Medtech Intelligence. Before becoming a journalist she worked as a biomedical scientist at St Thomas' Hospital in London for 10 years.
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Latest From Neena Brizmohun
Two products that the European Medicines Agency this week said should not be authorized for sale in the EU are already approved in the US.
The UK drug regulator has granted volanesorsen a positive scientific opinion under its early access to medicines scheme for use in patients with familial chylomicronemia syndrome. The drug’s sponsor, Akcea Therapeutics, is hoping to get the drug approved in the EU, the US and Canada this year.
Eight EU marketing authorization applications are up for an opinion this week from the CHMP, the European Medicines Agency committee that recommends whether or not products should be approved.
Manufacturers of already-authorized medical device disinfectants and sterilants have 18 months to meet Health Canada’s new reclassification rule for such products.
Australia has introduced new civil penalties and amended criminal offense provisions for breaches of its therapeutic product advertising rules. More reforms to the advertising regulations are expected soon.
Australia has introduced new civil penalties and amended criminal offence provisions for breaches of its therapeutic product advertising rules. More reforms to the advertising regulations are expected soon.