FDA Offers New Clinical Trial Guidance for Oncology Accelerated Approval

FDA details its view of the “limitations” of single-arm trials in oncology drug development and invites comment on its favored approach going forward.  Becky Wood, Emily Marden, and Julea Lipiz explain. 

Missing Numbers: Seeking to Substantiate The Leaked EU Pharmaceutical Review

Pharma companies are currently assessing how the Pharma Review will affect their portfolios. Maarten Meulenbelt and Maria Koutsoupia discuss the need for analysis from the EU to support the Review’s claims, for example on the allegedly ‘invisible’ effect of losing €640 million in annual orphan drug revenues.

The CJEU Provides Further Clarity on the Application of the Global Marketing Authorisation Concept

On March 16, 2023 the Court of Justice of the European Union (CJEU) rendered an important judgment[1] for the pharmaceutical industry as it brings some clarification on the test to assess if two products have the ‘same active substance’ and therefore belong to the same Global Marketing Authorisation (GMA). This is a crucial determination as products falling within the GMA of an existing product do not benefit from an independent period of regulatory data protection (RDP) and marketing protection.


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.


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.

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.

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.



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