Acting Commissioner says she is ‘really going to be pushing’ to have clinical trials conducted in the community. CDER’s Cavazzoni and CBER’s Marks discuss master protocols, decentralized trials, and real world evidence at DIA’s annual meeting.
When officials from the US Food and Drug Administration are asked what changes the COVID-19 pandemic will leave in its wake, one thing is at the top of their list: transformation in the conduct of clinical trials. Leaders offered more details on what this may look like in a 1 July session of the Drug Information Association’s annual meeting.
Speaking at DIA's FDA Town Hall, FDA Acting Commissioner Janet Woodcock said she is “really going to be pushing” to...
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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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the potential consequences for sponsors if enrollment goals are not met, stakeholders say in comments on the DAP draft guidance.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.
