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.
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.
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.
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.
New measures for the security assessment of data transfers from China to other countries could make it harder for international pharma companies with China operations to transfer health data out of the country. Lianying Wang explains.