56 Total results for product and free and sample content found
13 May 2022
Disclosure & transparency experts from Sarepta, Boehringer Ingelheim, Bayer and Merck KGaA discuss the ins and outs of CTIS.
By Ian Schofield 27 Jan 2021
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.
27 Jan 2021
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.
By Ian Schofield 27 Nov 2020
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.
By Ferdous Al-Faruque 27 Nov 2020
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.
By Elizabeth Orr 27 Nov 2020
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.
By Vibha Sharma 27 Nov 2020
An EU pilot project will assess whether there is sufficient demand from companies to obtain simultaneous scientific advice from EU national competent authorities.
By Brian Yang 27 Nov 2020
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.
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