56 Total results for product and free and sample content found
TrialScope Disclose
31 Mar 2022
Disclosure & transparency experts from Sarepta, Boehringer Ingelheim, Bayer and Merck KGaA discuss the ins and outs of CTIS.
Topic Regulation
TrialScope Atlas
07 Feb 2022
Clinical trial disclosure is a complex process driven by a constantly evolving collection of registry rules and health authority regulations.
Topic Regulation
Pink Sheet
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.
Topic Regulation Brexit Pharma-Brexit
In Vivo
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.
Pink Sheet
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.
Topic Pharma-Brexit Brexit Regulation
Medtech Insight
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.
Topic Approvals Compliance Regulation
Medtech Insight
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.
Topic Coronavirus Diagnostics In Vitro Diagnostics Regulation
Pink Sheet
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.
Topic EU Innovation Regulation
Pink Sheet
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.
Topic China Regulation Compliance
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