Clinical trials or literature reviews? Get real or face stricter rules
This article was originally published in Clinica
One of the EU's most powerful regulatory authorities, the UK's Medicines and Healthcare products Regulatory Agency (MHRA) believes there are too few clinical trials being undertaken with medical devices. Instead companies tend to favour the less costly literature review route. But is this sufficient to minimise as far as possible the risks associated with device use? Or will there be a backlash with regulators pressing in the near future for stricter clinical trials rules? Consultant Trevor Lewis suggests that companies should take a more objective look at their clinical trial decision-making.
You may also be interested in...
To be more transparent and allow more public discourse, the HHS now requires all its agencies to publish documents it uses to rationalize proposed rules and demonstration projects.
Dr Reddy's is poised to expand its OTC offering in Russia and certain CIS countries by snapping up a basket of allergy brands from India's Glenmark.
Second read-out maintains 94% level of efficacy, with a very early signal that it could outperform Pfizer’s rival mRNA candidate in preventing severe cases.