Commissioner tells House hearing that agency study found troubling drop in innovative competition; clinical trial reform, including encouraging surrogate markers, could speed development of products that may create pricing pressure on brands.
As the US FDA continues its implementation of the 21st Century Cures Act, the agency will be releasing guidance "very soon" on how sponsors can conduct "seamless" trials as part of the law's broader effort to modernize clinical studies, Commissioner Scott Gottlieb announced.
Testifying July 25 before the House Energy and Commerce Subcommittee on Health on the implementation of the Cures Act, Gottlieb...
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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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the potential consequences for sponsors if enrollment goals are not met, stakeholders say in comments on the DAP draft guidance.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.
