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The end of the two-tier system: A comparative review of the FDA’s 2024/2025 shift on biosimilar interchangeability and its impact on global harmonisation
IDMP after the API: From one-time submission to living data governance
Mapping early and often FDA interaction in rare disease programmes: Building the path from discovery to registration
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Latin America: From low-cost venue to strategic platform in veterinary clinical research
A lifecycle oversight of veterinary medicines regulation in Latin America
A career in veterinary regulatory affairs: Roles and competencies across the product lifecycle
November 2025 – Contents: Veterinary medicines sessions
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The FDA Quality Management System Regulation and the limits of harmonisation: Building a global QMS around a common core
China’s volume-based procurement revolution: How policy, procurement and industrial strategy are reshaping medical device market access
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- Industry news
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US could ‘seize’ drug patents with unused Reagon-era law
The Biden administration sets new policy direction that could see the US federal government ‘seizing’ patents from publicly-funded medicines.
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