Tag: Life Sciences

COVID-19: Weekly Life Sciences Digest – Initiatives for Fast Tracking Treatments and New FDA Guidance

Phil Mitchell, Edward Turtle, Sana Shakir, Julia Maskell and Alicia Johnson-Cole

With COVID-19 heralding unprecedented changes in the sector, our life sciences products experts provide a weekly summary of key international developments to keep you up to date.

COVID-19: Weekly Life Sciences Digest – International Collaboration and New Guidance in the EU and UK

Sarah-Jane Dobson, Edward Turtle and Julia Maskell

With COVID-19 heralding unprecedented changes in the sector, our life sciences products experts provide a weekly summary of key international developments to keep you up to date.

COVID-19: Weekly Life Sciences Digest – Guidance for Industry in EU, UK and US

Natasha Leskovsek, Sarah-Jane Dobson, Edward Turtle, Harriet Jones and Julia Maskell

With COVID-19 heralding unprecedented changes in the sector, our life sciences products experts provide a weekly summary of key international developments to keep you up to date.

The EU delays application of its new medical devices regime

Sarah-Jane Dobson and Ross Lennox

The EU has decided to postpone application of its new medical regime by one year. Although COVID-19 is cited as the reason, the delay is no doubt welcomed by an industry that has lobbied for postponement of the regime for some time because of perceived issues with its implementation.

The ever-changing COVID-19 regulatory landscape: The European Commission issues guidance on the manufacture of certain medical supply products for COVID-19

Sarah-Jane Dobson and Olivia Flasch

The regulatory environment for rapid production of COVID-19 medical supplies changes on a daily basis. Most recently, the European Commission has weighed in to provide some Europe-wide insight. The guidance provided only serves to underline the significant pressures that all of those in these areas are having to grapple with, as well as the considerable complexity of applicable regulatory regimes.

UK-specific guidance for manufacture and supply of certain medical devices for COVID-19

Sarah-Jane Dobson

As noted in our previous overview article, it is vital that interested companies continue to monitor and strategically act on the rapidly changing government position on the regulation of specific medical supply product types in the context of COVID-19.