Remove Assay Development Remove Therapies Remove Trials Remove Workshop
article thumbnail

Article FDA Thank You The next chapter in the ctDNA story: Still promising, not ready for prime time

Agency IQ

The next chapter in the ctDNA story: Still promising, not ready for prime time A recent workshop summed up the state of play for circulating tumor DNA. The assessment of this benefit typically relies upon the use of specific endpoints to measure this clinical benefit, generally within the context of a clinical trial. [

FDA 40
article thumbnail

Article EMA Thank You EMA finalizes clinical anticancer therapeutic guidance update

Agency IQ

EMA finalizes clinical anticancer therapeutic guidance update In a newly finalized revision, the EMA’s guideline covering all aspects of clinical development of anticancer therapeutics has expanded its already broad scope. This enables patient selection, stratification and other adjustment in clinical trial design planning.