India plans pivotal tweaks to its three-layered review process for clinical trial-related clearances – a move that is expected to pare approval timelines significantly and improve predictability for sponsors who have been generally cautious, over the recent past, about placing studies in the country.
A key panel of government functionaries has stipulated plans to revamp the three-tier approach for clinical trial approvals in India, bringing significant relief to the beleaguered clinical research sector in the country.
India currently follows a layered review process for clinical trial-related approvals, under which applications are initially evaluated by specialized Subject Expert Committees (SECs), whose recommendations are then generally
Sanofi’s Xenpozyme and Sentynyl’s Nulibry are the first two case studies the FDA is using to continue educating rare disease sponsors on best practices.
Marcus Vass and Vladimir Murovec of international law firm Osborne Clarke tell the Pink Sheet what the government's planned HDRS might mean for industry, and how it compares with the European Health Data Space.
The European Health Data Space framework will allow companies to accelerate R&D processes and identify new molecular targets faster by facilitating centralized access to certain types of high-quality data, Finland’s Orion Pharma says.
