Many assays have integrated, built-in, or internal controls to demonstrate their operability at specific procedural steps. What role do these built-in controls play in quality control to assure ...
The External Controls Draft Guidance provides FDA’s thinking specifically with regard to a trial that has a single treatment arm and single control arm. The draft guidance proposes that in addition to ...
Results from single-arm clinical trials can be contextualized by comparing against external controls (ECs) derived from real-world data (RWD). However, lack of randomization and differences in ...
The US Food and Drug Administration (FDA) has now published four draft guidances spelling out how it will consider real-world data (RWD) in regulatory decision-making, from the use of electronic ...
This is the second article in Microbiologics’ series on Optimal QC in the Clinical Laboratory. In a previous article, we highlighted the importance of external quality control products for QC in the ...
Delandistrogene moxeparvovec showed significant long-term stabilization or slowed progression in DMD patients over 3 and 5 years compared to external controls. Clinical trials demonstrated ...
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