Leukemia & Lymphoma Society worked with US FDA on umbrella trial strategy to accelerate development of new targeted therapies in molecularly-defined subsets of AML.
A new master trial for testing investigational drugs in acute myeloid leukemia has benefited from input from the US FDA and could enable speedy approvals in small, molecularly-defined subsets of patients with the disease, according to the Leukemia & Lymphoma Society (LLS), the trial's sponsor.
The society designed the "Beat AML" master protocol to use genomic insights to energize development of new therapies for AML,...
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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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the potential consequences for sponsors if enrollment goals are not met, stakeholders say in comments on the DAP draft guidance.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.
