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There may not be a great deal in the new UK-EU trade and cooperation deal for the life sciences industry but a new working group could act as the forum for constructive discussions on regulatory cooperation.
The turn of the year is a chance to reflect on times past and the future, to make resolutions and look ahead to changes for the better. With Brexit in mind, this is the time to prophesize on UK medtech’s immediate future.
Regulations that would allow the UK MHRA to work as a standalone regulator in the event of a no-deal Brexit have been laid before parliament. They cover a host of areas including new drug approval procedures, conversion of existing EU marketing authorizations into UK ones, pediatric and orphan exclusivities, imported medicines, and regulatory fees.
As concerns continue to mount over a potential shortage of medical devices due to the closure of ethylene oxide (EtO) facilities, the US agency is looking for nine sterilizers in a pilot project that could allow them to get facility and process changes approved faster.
The US FDA has authorized marketing of a combination diagnostic that can detect either COVID-19 or influenza. The agency hopes to encourage development of additional similar tests before the fall flu season.
An EU pilot project will assess whether there is sufficient demand from companies to obtain simultaneous scientific advice from EU national competent authorities.
Ex-China FDA Commissioner Bi Jingquan’s new role, a waiver of bioequivalence testing for hundreds of drugs, data accuracy requirements and a new crackdown on compliance issues.
Celltrion says it is ready to roll out its Remsima SC subcutaneous infliximab in Europe in the first quarter of 2020, after receiving a formal pan-European marketing authorization from the European Commission.
Although the EU MDR and IVDR will fall outside the scope of new post-Brexit medtech regulations for Great Britain in 2021, the UK MHRA says it has the chance of developing its own world-leading regulatory regime.
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