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 European Medicines Agency (EMA) plans to release a reflection paper regarding when external controls can be used to generate evidence to support regulatory decisions on drug approvals. The agency ...
The FDA Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) have issued draft guidance describing sponsors can leverage external controls, such ...
Clinical trials give patients hope — especially when all other available treatments have been exhausted. That hope compels patients to commit a substantial amount of time and effort for the chance to ...
Advances in genomics have enabled anticancer therapies to be tailored to target specific genomic alterations. Single-arm trials (SATs), including those incorporated within umbrella, basket, and ...
The External Controls Draft Guidance provides FDA’s thinking specifically with regard to a trial that has a single treatment arm and single control arm. The draft guidance proposes that in addition to ...
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