TrialScope Atlas

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

Medtech Insight

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

Generics Bulletin

Celltrion's Remsima SC Ready For Early 2020 Launch

By David Wallace 27 Nov 2020

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.

Topic Biosimilars Launches Regulation

Generics Bulletin

Alberta Is Second Canadian Province To Switch To Biosimilars

By David Wallace 27 Nov 2020

Alberta has become the second Canadian province to announce a biosimilar switching program, following the example set by British Columbia earlier this year. The move has been welcomed by Biosimilars Canada but criticized by originator-backed body Crohn’s and Colitis Canada.

Topic Biosimilars Regulation

Medtech Insight

As Expected, FDA Misses Fourth Consecutive Deadline For Releasing Draft QSR

By Shawn M. Schmitt 17 Nov 2020

The US FDA’s internal deadline of October 2020 for putting out a draft of its retooled Quality System Regulation is the fourth it failed to meet. The agency has been harmonizing its decades-old QSR with ISO 13485:2016 for more than two years.

Topic Regulation

Pink Sheet

England's HTA Body To Revamp Product Selection Processes

By Ian Schofield 29 Oct 2020

Proposals from NICE now under consultation are intended to boost the health technology assessment body’s efficiency, improve transparency and governance, and raise the quality of its guidance

Topic Regulation EU

Pink Sheet

EU Pharma Strategy To Balance Innovation Incentives and Competition

By Ian Schofield 09 Oct 2020

Delegates at this week’s TOPRA conference heard the European Commission’s “holistic” vision of what it would like to achieve through its pharmaceutical strategy, including incentives for innovation, security of the supply chain, product shortages, real world evidence and big data, and the availability and affordability of medicines.

Topic EU Artificial Intelligence Regulation

Chemist + Druggist Data

UK Sees PIP Codes Expand To Cover Hospital Drugs

By C+D Data 09 Sep 2020

Chemist + Druggist has expanded its “PIP code” system for UK pharmacy procurement to also encompass hospital drugs.

Topic BioPharmaceutical Regulation Biosimilars

Medtech Insight

UK Readies Medtech And Pharma Sectors For Regulatory Life Outside The EU

By Ashley Yeo 26 Aug 2020

Work has started on UK-only regulations for the medtech and medicines sectors, to ensure that the regulatory framework not only functions but can also react swiftly to needs after the UK leaves the EU. This article is part two of two.

Topic EU Medtech-Brexit Regulation Brexit