TrialScope Atlas

19 May 2022

Clinical trial disclosure is a complex process driven by a constantly evolving collection of registry rules and health authority regulations.

Topic Regulation

Disclosure & transparency experts discuss the ins and outs of CTIS

13 May 2022

Disclosure & transparency experts from Sarepta, Boehringer Ingelheim, Bayer and Merck KGaA discuss the ins and outs of CTIS.

Topic Regulation

UK BIA To Push For Post-Brexit Regulatory Agreement With EU

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

The Times They Are A-Changin’: Opportunities In Medtech Regulation For The UK After Brexit

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.

Topic Regulation Market Access Medtech-Brexit

How The UK Regulatory System Would Work In A No-Deal Brexit – Part 1

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

FDA Launches Pilot Program To Streamline EtO Facility, Process Changes

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

FDA Clears CDC Diagnostic For COVID-19 And Influenza

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

EU Countries Test Offering Simultaneous Scientific Advice

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

China Regulatory Express Former CFDA Commissioner Bi Makes Comeback

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