The UK veterinary medicines industry needs to respond by March 31 to a consultation on proposed changes to the UK Veterinary Medicines Regulations which could boost data protection for regulatory submissions, incentivising innovation. However, companies need to be wary of potential increases in regulatory burden in other areas. Chris Boyle explains.
https://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.png00Dr. Chris Boylehttps://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.pngDr. Chris Boyle2023-03-17 06:00:142023-03-16 15:17:09Four Ways New Legal Proposals Could Boost the Animal Health Industry in Great Britain
In the first of a series on surviving the current financial and regulatory environment, Torrey Cope looks at how life sciences companies can reduce difficulties in getting new products approved by the U.S. Food and Drug Administration through effective written submissions.
https://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/05/GLS-Blog_Generic-imagery-13.png606833Torrey Copehttps://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.pngTorrey Cope2023-03-15 16:32:572023-04-06 17:00:00A Challenging Regulatory Environment Means More Care Needed with FDA Submissions
The original agreement for the UK’s withdrawal from the EU affected the availability of medicines in Northern Ireland and created issues for importers of medicinal products. The new ‘Windsor Framework’ is better for the industry, as Marie Manley and Bronwyn Tonelli explain.
This week, U.S. healthcare providers met with a Medicare reimbursement panel to discuss remote patient monitoring, remote therapeutic monitoring, and considerations for determining reimbursement. Jon Zucker, Meenakshi Datta, and Sama Kahook analyze some key themes.
One year after the EU Veterinary Medicines Regulation (VMR) came into force, novel medicine developers have an important opportunity to shape its implementation. Chris Boyle and Bronwyn Tonelli look at what’s at stake for an industry which is embracing technological advancement, but which faces twice the administrative burden of the human medicine industry.
https://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.png00Dr. Chris Boylehttps://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.pngDr. Chris Boyle2023-02-22 11:32:322023-02-22 11:32:32Consultations On EU’s New Law Aimed At Boosting Novel Animal Medicines
The pharma industry was unhappy about a rule which prevented U.S. accountants and consultants, and even some in-house staff at pharma companies, from providing services to medical services companies in Russia. Carys Golesworthy explains how this has now changed.
https://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.png00Carys Golesworthyhttps://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.pngCarys Golesworthy2023-02-14 10:59:582023-02-14 10:59:58International Pharma Can Now Use U.S.-based Accountants in Russia
On 31 January 2023, the internally circulated version of the European Commission’s far-reaching overhaul of the EU’s pharma legislation was leaked, and published by Politico. Here, initial impressions of the biggest surprises in the document are given by Maarten Meulenbelt, Chris Boyle, and Zina Chatzidimitriadou.
https://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/05/GLS-Blog_Generic-imagery-11.png606833Maarten Meulenbelthttps://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.pngMaarten Meulenbelt2023-02-06 16:09:332023-02-08 10:48:46Six Surprises In The Leaked European Pharmaceutical Review
September 24The Francis Crick Institute, 1 Midland Road, London, NW1 1AT, UK
Archives
Categories
We use cookies to ensure that we give you the best experience on our website. If you continue to use this site we will assume that you are happy with it.Ok
Four Ways New Legal Proposals Could Boost the Animal Health Industry in Great Britain
The UK veterinary medicines industry needs to respond by March 31 to a consultation on proposed changes to the UK Veterinary Medicines Regulations which could boost data protection for regulatory submissions, incentivising innovation. However, companies need to be wary of potential increases in regulatory burden in other areas. Chris Boyle explains.
(more…)
Dr. Chris Boyle
London
cboyle@sidley.com
A Challenging Regulatory Environment Means More Care Needed with FDA Submissions
In the first of a series on surviving the current financial and regulatory environment, Torrey Cope looks at how life sciences companies can reduce difficulties in getting new products approved by the U.S. Food and Drug Administration through effective written submissions.
Torrey Cope
Washington, D.C.
tcope@sidley.com
The Windsor Framework’s Implications for Pharmaceutical Companies
The original agreement for the UK’s withdrawal from the EU affected the availability of medicines in Northern Ireland and created issues for importers of medicinal products. The new ‘Windsor Framework’ is better for the industry, as Marie Manley and Bronwyn Tonelli explain.
Maria Isabel Manley
London
mmanley@sidley.com
Bronwyn Tonelli
Trainee Solicitor
btonelli@sidley.com
Healthcare Providers Laud Remote Monitoring as Medicare Contractors Look Forward
This week, U.S. healthcare providers met with a Medicare reimbursement panel to discuss remote patient monitoring, remote therapeutic monitoring, and considerations for determining reimbursement. Jon Zucker, Meenakshi Datta, and Sama Kahook analyze some key themes.
Meenakshi Datta
Chicago
mdatta@sidley.com
Jon S. Zucker
Washington D.C.
jzucker@sidley.com
Sama E. Kahook
Washington, D.C.
skahook@sidley.com
Consultations On EU’s New Law Aimed At Boosting Novel Animal Medicines
One year after the EU Veterinary Medicines Regulation (VMR) came into force, novel medicine developers have an important opportunity to shape its implementation. Chris Boyle and Bronwyn Tonelli look at what’s at stake for an industry which is embracing technological advancement, but which faces twice the administrative burden of the human medicine industry.
Dr. Chris Boyle
London
cboyle@sidley.com
Bronwyn Tonelli
Trainee Solicitor
btonelli@sidley.com
International Pharma Can Now Use U.S.-based Accountants in Russia
The pharma industry was unhappy about a rule which prevented U.S. accountants and consultants, and even some in-house staff at pharma companies, from providing services to medical services companies in Russia. Carys Golesworthy explains how this has now changed.
Carys Golesworthy
Washington, D.C.
cgolesworthy@sidley.com
Six Surprises In The Leaked European Pharmaceutical Review
On 31 January 2023, the internally circulated version of the European Commission’s far-reaching overhaul of the EU’s pharma legislation was leaked, and published by Politico. Here, initial impressions of the biggest surprises in the document are given by Maarten Meulenbelt, Chris Boyle, and Zina Chatzidimitriadou.
Maarten Meulenbelt
Brussels
mmeulenbelt@sidley.com
Dr. Chris Boyle
London
cboyle@sidley.com
Zina Chatzidimitriadou
London
zchatzidimitriadou@sidley.com
Resources
Upcoming Events
Swiss MedTech 2024: Harnessing Market Dynamics for Profitability
- ESG and its development in the EU
- Seizing the opportunities of Artificial Intelligence
- Health data and clinical trials
(more…)Data Integrity and Governance Workshop
Sidley Healthcare Investment Conference 2024
Archives
Categories