Lundbeck executive calls for adaptive trial designs, transdiagnostic approach, and more scientific discussions between sponsors and the US Food and Drug Administration.
How can the US Food and Drug Administration promote development of drugs in the central nervous system space? Katrin Rupalla, senior VP, head of regulatory affairs, medical documentation and R&D quality at Lundbeck Inc., believes the agency should apply an approach similar to that used in oncology for products being developed for dementia and cognitive impairment.
Rupalla spoke at a meeting FDA convened for stakeholders to provide review staff in the Center for Drug Evaluation and...
A new research ethics review system for multi-site clinical trials in Canada is expected to help improve study start-up times, avoid unnecessary duplication and boost the country’s competitiveness on a global stage.
With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be implemented.
Contract research organizations (CROs) in India must gear up to comply with new registration requirements coming into effect in April 2025 that aim to enhance the quality and integrity of clinical trials, as well as of any bioavailability and bioequivalence studies conducted by them.
With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be implemented.
Contract research organizations (CROs) in India must gear up to comply with new registration requirements coming into effect in April 2025 that aim to enhance the quality and integrity of clinical trials, as well as of any bioavailability and bioequivalence studies conducted by them.
The agency also should explain the potential consequences for sponsors if enrollment goals are not met, stakeholders say in comments on the DAP draft guidance. Some commenters urged the FDA to apply waiver criteria flexibly, especially for rare diseases.
