17 Total results for product and free and sample content found
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
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
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
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
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
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
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.
Chemist + Druggist Data
By C+D Data 09 Sep 2020
Chemist + Druggist has expanded its “PIP code” system for UK pharmacy procurement to also encompass hospital drugs.
Medtech Insight
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
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